Clinical trial NCT04217057
Conditions: Head and Neck Cancer
Sponsor: Washington University School of Medicine
Start date: 2020-02-07; Completion date: 2023-02-07
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.

Detailed description:

Arms: arm 1: -64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed
Interventions: intervention 1: 64Cu-DOTA-ECL1i
Intervention descriptions: intervention 1: Will be produced by the Cyclotron Facility at Washington University School of Medicine

Protocol documents:
Prot_SAP_000.pdf: 
VI. PROTOCOL  
 
 
Imaging CCR2 Receptors with 64Cu-DOTA-ECL1i in Head and Neck Cancer  
 
Principal Investigator 
Farrokh Dehdashti, M.D. 
Washington University School of Medicine 
660 S. Euclid, Campus Box 8223 
St. Louis, MO  63110 
Telephone: 314-362-1474 
E-mail: dehdashtif@wustl.edu 
Protocol Version # 5 
HRPO # 201912003 Version Date: 08/28/2023 
 
Sub-Investigators 
Ryan Jackson, M.D. 
Department of Surgery (Head & Neck) 
Telephone: (314) 362-7509 
Email: jackson.ryan@wustl.edu 
 
Yongjian Liu Ph.D. 
Department of Radiology 
Tel: (314) 362-8431 
Email: yongjianliu@wustl.edu 
 
Ningying Wu, MD, PhD (statistician) 
Division of Biostatistics 
Telephone: (314) 747-8162 
Email: wun@wustl.edu 
 
Rebecca Chernock, M.D. 
Department of Pathology & Immunology 
Telephone: (314) 362-0101 
Email: rchernock@wustl.edu 
 
 
Kooresh I. Shoghi, Ph.D. 
Department of Radiology 
Telephone: (314) 362-8990 
Email: shoghik@wustl.edu 
 
Sidharth Puram, MD, PhD 
Department of Otolaryngology 
Telephone: (314) 362-7395 
Email: sidpuram@wustl.edu 
Chieh-Yu Lin, MD, PhD 
Department of Pathology & Immunology 
Telephone: (314) 273-6993 
Email: chieh-yu@wustl.edu  
Richard Laforest, PhD.  
Department of Radiology 
Telephone: 314-362-8423 
Email: rlaforest@wustl.edu  
Study Drug: 64Cu-DOTA-ECL1i 
Applicable IND(s): 137620 – Dr. Robert Gropler 
Clinical Trials.gov #: NCT04217057 
 
 


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Imaging CCR2 Receptors with 64Cu-DOTA-ECL1i in Head and Neck Cancer  
Protocol Revision History 
 
Initial submission version:  10/14/2019 
 
Date 
Protocol Section  
Summary of Changes 
Submission 
Information  
11/13/2019 6.10.0 Regulatory and Reporting 
Requirements 
Updated to match 
SOP for Siteman 
Cancer Center 
Received 11/2019 
Pending RDRC 
review 
Pre HRPO Review 
Pre FDA submission 
FDA submitted Jan 
2020 
  
04/14/2020 
Title Page 
Update HRPO 
number, CT.Gov 
number, protocol 
version number and 
date 
PRMC approved 
07/22/2020 
 FDA 
Dec 2020 
04/14/2020 
Footer all pagers 
Update date and add 
page numbers 
PRMC approved 
07/22/2020 FDA 
Dec 2020  
4/14/2020 
6.1.0 Background 
Additional 
information on 
immunostaining for 
CCR2  
PRMC approved 
07/22/2020 
FDA Dec 2020  
4/14/2020 
6.2.0 Objectives 
Addition of an 
objective related to 
assessing the 
relationship between 
CCR2 expression 
and HPV status  
PRMC approved 
07/22/2020 
FDA Dec 2020 
04/14/2020 
6.5.2 Patient Population 
Add information on 
analysis of HPV+ 
and HPV- tissue 
samples 
PRMC approved 
07/22/2020 
 FDA  Dec 2020 
4/14/2020 
6.5.9 Immunohistochemical 
Evaluation of Chemokinetic 
Receptors 
Adding a 
retrospective section 
to assess the 
expression of CCR2 
in HPV+ and HPV- 
HNSCC metastasis 
PRMC approved 
07/22/2020 
FDA  Dec 2020 


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Renewal Version 2a Dated 11/02/2020 
11/09/2020 
Title Page 
Update protocol 
version number and 
date for renewal 
submission  
PRMC approved 
11/25/2020 
 FDA Feb 2022 
Protocol Amendment Version 3 03/31/21 
03/31/21 
Title Page 
Update protocol 
version number and 
date for renewal 
submission  
 
03/31/21 
Footer all pagers 
Update version 
number and date 
 
03/31/21 
Throughout protocol 
Correct 
syntax/punctuation 
 
03/31/21 
Study Coordinators 
Remove Helen 
Kaemmerer, add 
Austin Turner 
 
03/31/21 
Schema 
Revise to include 
patients who will 
receive other 
definitive therapy  
 
03/31/21 
6.4.0 Inclusion Criteria/ 
Exclusion Criteria 
Revise to include 
patients who will 
receive other 
definitive therapy 
 
03/31/21 
6.5.2 Patient Population 
Revise to include 
patients who will 
receive other 
definitive therapy 
 
03/31/21 
6.5.8 Safety & Clinical 
Follow-Up 
Revise to include 
patients who will 
receive other 
definitive therapy 
 
03/31/21 
6.12.0 Data Submission 
Schedule 
Add Tissue 
Collection Form and 
submission schedule 
 
03/31/21 
6.13 
Study Calendar 
Add tissue collection 
 
 
Renewal Version 3a Dated 10/12/2021 


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10/12/2021 
Title Page 
Update protocol version 
number and date for 
renewal submission  
PRMC approved 
11/02/2021 
FDA Feb 2022  
Amendment V4 02/15/2022 
02/15/2022 
Title Page 
Update protocol version 
number and date for 
submission  
Oncore Updated Feb 
15, 2022 
FDA Feb 2022 
Title Page 
Update Study team 
members (statistician, 
pathology, radiology 
team) 
Footer all pagers 
Update version number 
and date 
Renewal Version 4a 09/12/2022 
09/12/2022 
Title Page 
Update protocol version 
number and date for 
renewal submission  
PRMC 10/11/2022 
FDA 02/06/2023  
Footer all pagers 
Update version number 
and date 
Renewal / Amendment Version 5 08/28/2023 
08/28/2023 
Title Page 
Update protocol version 
number and date for 
renewal submission 
Remove study coordinators 
Pending PRMC 
Pending FDA  
Footer all pagers 
Update version number and 
date Fix pagination error(s) 
Formatting all pages  
Document consistency fix 
spacing etc 
Contents 
Update table of Contents 
6.5.3 PET 
Imaging 
6.13 Study 
Calendar 
Clarify metabolites are 
collected whenever 
possible 
6.8.0 Risks and Benefits 
Fix typographical error 
referencing PDAC 
&Clarify metabolites are 
collected whenever 
possible  
 
 


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Contents 
SCHEMA ...................................................................................................................................6 
6.1.0 Background .....................................................................................................................7 
6.2.0 Objectives ..................................................................................................................... 10 
6.3.0 Statement of Qualifications ............................................................................................ 10 
6.4.0 Inclusion Criteria/ Exclusion Criteria ............................................................................. 10 
6.4.1 Inclusion of Women and Minorities ........................................................................... 11 
6.4.2 Registration Procedures & Screen Failures................................................................. 11 
6.5.0 METHODS ................................................................................................................... 11 
6.5.1 Study Design ............................................................................................................. 11 
6.5.2 Patient Population ...................................................................................................... 11 
6.5.3 PET Imaging ............................................................................................................. 12 
6.5.4 PET Image Processing and Analysis .......................................................................... 13 
6.5.5 Vital Signs ................................................................................................................. 14 
6.5.6 Clinical Laboratory Testing ....................................................................................... 14 
6.5.7 Electrocardiograms (ECGs) ....................................................................................... 15 
6.5.8 Safety & Clinical Follow-Up ..................................................................................... 16 
6.5.9 Immunohistochemical Evaluation of Chemokinetic Receptors ................................... 16 
6.6.0 Drug Preparation ........................................................................................................... 16 
6.7.0 Statistics ........................................................................................................................ 17 
6.8.0 Risks and Benefits ......................................................................................................... 17 
6.9.0 Record Keeping ............................................................................................................. 18 
6.10.0 Regulatory and Reporting Requirements ........................................................................ 18 
6.10.1 
Sponsor – Investigator / WU PI Reporting Requirements ....................................... 19 
6.10.1.1 
Reporting to the Human Research Protection Office (HRPO) at Washington 
University) 19 
6.10.1.2 
Reporting to the Quality Assurance and Safety Monitoring Committee 
(QASMC) at Washington University ................................................................................. 19 
6.10.1.3 
Reporting to the FDA ..................................................................................... 19 
6.10.2 
Exceptions to Expedited Reporting ........................................................................ 20 
6.11.0 Data and Safety Monitoring ........................................................................................... 20 
6.12.0 Data Submission Schedule ............................................................................................. 21 
6.13 
Study Calendar .............................................................................................................. 22 
6.14 
References ..................................................................................................................... 23 
APPENDIX A: Definitions for Adverse Event Reporting .......................................................... 25 
APPENDIX B: Reporting Timelines ...........................................................................................3 
 
 
 


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SCHEMA 
 
Imaging CCR2 Receptors with 64Cu-DOTA-ECL1i in Head and Neck Cancer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research 64Cu-DOTA-ECL1i-
PET/CT  
Patients with New Diagnosis of Head & Neck Cancer who are 
Candidates for Surgical Resection Or non-surgical Candidates 
with Sufficient Biopsy for Analysis of CCR2 (n=20) 
Baseline Standard of Care Clinical and 
Radiological Studies Including CT and/or MRI 
Tumor Tissue Analysis  
For Assessment of CCR2 Expression 
Per available tissue from either SOC Surgical Resection OR 
SOC Diagnostic Biopsy   


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7 
6.1.0 Background  
Chemokines, also known as chemoattractant cytokines, are a super family of small secreted 
proteins initially characterized by their ability to induce leukocyte migration. They are small 
proteins known as cytokines that have chemoattractant properties and, thus, are called chemokines. 
One of their most critical functions is governed by the specific amino acid sequence (or motif) of 
Glu-Leu-Arg (or ELR) immediately preceding the first cysteine of their CXC motif. ELR+ CXC 
chemokines are considered angiogenic, whereas ELRCXC chemokines are considered 
angiostatic1. To date, more than 50 chemokines and 20 chemokine receptors have been identified. 
Chemokines and their receptors have a highly conserved sequence throughout the genetic tree 2. 
They are grouped into 4 distinct groups (C, CC, CXC, and CX3C), which are based on the number 
and position of conserved cysteine residues near the NH2 terminus of the molecule 3. The specific 
effects of the chemokines on their target cells are mediated by members of a family of 7-
transmembrane-spanning, G-protein–coupled chemokine receptors. Most chemokines are able to 
bind with high affinity to multiple receptors while their receptors usually are restricted to a single 
subclass and induce an intensive signaling cascade of activated second messengers that lead to cell 
motility and multiple other functional effects in the target cells. Chemokines insert their cellular 
trafficking and processes are influenced significantly by chemokines via their receptors.  
Chemokine Receptors: Most chemokine receptors bind specifically, but indiscriminately 
to their chemokine ligands. Chemokine receptors exist in many epithelial and hematopoietic cells. 
These receptors are members of the 7-TM GPCR super family. Like chemokines, chemokine 
receptors also share structurally conserved/homologous regions, which allow their subgrouping 
classification. In general, upon binding to their ligands, chemokine receptors undergo 
conformational changes that allow the binding of G proteins to intracellular loop epitopes and the 
carboxy terminal tail of the receptors 3. The second intracellular loop of the receptors contains an 
Asp-Arg-Tyr-Leu-Ala-Ile-Val (DRYLAIV) motif, which is missing in the nonsignaling receptors 
and does not permit G-protein coupling 2 .The chemokine receptors that do not bind to G proteins 
may act in synchrony with other proteins to support their effects. Examples of these alternative 
cohorts include b-arrestin, integrins, and growth factor receptors 4-9.  
Chemokines are vital for leukocyte migration and activation, and physiologically they have 
been implicated in various immune, inflammatory and activation responses such as allergic 
disease, atherosclerosis, and wound healing. Furthermore, chemokines play an important role in 
the neoplastic processes of many organs and in determining the location of the metastatic spread 
of cancer cells. For example in squamous cell carcinoma of head and neck, chemokine receptors 
orchestrate critical functions in oral tumorigenesis by favoring angiogenesis, tumor growth and 
metastasis 10,11. In prostate cancer, multiple chemokines and their receptors (including CCR5, 
CCR7, CCR9, CXCR1, CXCR2, CXCR3, CXCR4, CXCR5, CXCR7) are involved in the 
multistep process of metastasis 5,8,12-15. In cervical cancer, CXCR4 receptor has been shown to play 
an important role during cervical cancer invasion 16. In addition, CXCR7 expression has been 
shown to predict poor disease-free and disease-specific survival in cervical cancer patients, and 
might be a promising new therapeutic marker. In a large majority of cases, CXCR7 is co-expressed 
with CXCR4 and/or EGFR, supporting the hypothesis that these receptors assist in CXCR7 signal 
transduction 17. CXCR4 has been found to be upregulated in several other cancers such as breast, 
prostate, lung, bladder, ovarian, renal, oesophageal, colorectal, and pancreatic cancer, and 
lymphoma, melanoma, osteosarcoma, neuroblastoma, etc. 18. In addition, high level of CXCR4 
expression correlated with tumor progression and metastasis 19,20, as well as poor prognosis and 
resistance to chemotherapy 21,22. Thus, these receptors provide an important target for imaging and 
treatment of various types of cancers.  
 
CCR2 in Head & Neck Cancer: The importance of chemokines and their cognate 
receptors in head and neck cancers is being revealed by increasing amount of studies. Recently, 


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8 
the expression of CXCR2 was reported substantially higher than that in paraneoplastic tissue in 
laryngeal squamous cell carcinoma 23. Elevated expression was significantly related with lymph 
node metastasis, histological grade, and 5-year survival 23. Thus, CXCR2 expression could be 
considered as a potent prognostic marker for laryngeal squamous cell carcinoma patients 23. 
Several studies have also documented the significance of CXCR4 in HNSCC tumor progression 
and organ-specific metastasis24,25. Wang et al investigated the expression of CXCR4 in 
nasopharyngeal carcinoma tissues, and they found that CXCR4 expression was elevated in tumor 
tissues and the increased expression was correlated with metastatic rates in patients as well as poor 
overall survival 26. This finding was consistent with another study which reported that CXCR4 
mRNA was significantly higher in HNSCC tissues than in paraneoplastic tissues and its expression 
were associated with lymph node metastasis and distant metastasis 27. These findings clearly 
demonstrate that CXCR4 could also be used to predict prognosis and metastasis in HNSCC 
patients.  
Chen et al. reported that a 64I mutation of the CC chemokine receptor-2 (CCR2) is 
significantly associated with oral cancer susceptibility 28. Also, another group demonstrated that 
mutation of MCP-1 gene, which encodes CCR2 ligands, increased the expression of MCP-1 
resulting in elevated CCR2 activity which could increase the risk for developing oral squamous 
carcinoma29. The authors predicted that MCP-1 and CCR2 could be used as genetic markers for 
diagnosis of oral carcinoma squamous29. In addition, Fujita et al. found that The CCL2-CCR2 axis 
is associated with lymphatic metastasis in oral squamous cell carcinoma30. Yang et al. have shown 
that CCL2-CCR2 axis could promote nasopharyngeal carcinoma (metastasis by activating 
ERK1/2-MMP2/9 pathway. This study helps to develop novel therapeutic targets for distant 
metastasis in nasopharyngeal carcinoma31. Another CC chemokine receptor, i.e., CCR7, which 
plays a critical role in the migration of activated dendritic cells to regional lymph nodes, was also 
found elevated in HNSCC tumor tissues compared with paraneoplastic tissues and the elevated 
expression of CCR7 was correlated with lymph metastasis and tumor tissue differentiation status27. 
Another study evaluated the expression of CCR7 in primary and metastatic tumor cell lines and 
biopsies from both primary and metastatic lesions, and it was found that CCR7 expression was 
elevated in metastatic cells and tissues27. These findings reveal an important role of CCR7 in 
mediating the metastasis and tumor malignancy in head and neck squamous cell cancer patients. 
Taken together, accumulating evidence indicates that the altered expressions of various chemokine 
receptors (and their cognate ligands as well) in head and neck squamous cell cancer are associated 
with different cellular events including cell survival, tumor progression, and metastasis. The 
expression of chemokine receptors is associated with tumor cell differentiation and prognosis of 
head and neck squamous cell cancer patients. Moreover, their expression is also, to some degree, 
histologically specific, i.e., the expression of these chemokine receptors indicates it is the 
squamous cell carcinoma rather than other types (such as adenoid cystic carcinoma)32. These 
features, along with other tumor biomarkers, may help oncologists to assess their patients more 
thoroughly 
In the last few decades, human papillomavirus (HPV) has emerged as the key etiologic 
factor driving the rising incidence of oropharyngeal squamous cell cancer 33, 34 HPV-related 
oropharyngeal squamous cell cancer has emerged as a distinct clinical entity of head and neck 
cancer with expected high survival. This recognition has led to the investigation of whether a 
population of patients can be identified who can safely undergo treatment de-escalation, in an 
effort to minimize long-term treatment toxicity while maintaining excellent survival. The 
relationship of HPV and CCR2 has not been established in head and neck cancer. As the number 
of patients in this study is limited and we often do not know the HPV status of the patients, it will 
be extremely important to assess the CCR2 expression in the cancer tissues of HPV+ and HPV- 
patients to understand better the relationship of CCR2 expression and HPV. In future studies, we 
will be able to assess whether presence of CCR2 in each group is predictive of worse prognosis 


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9 
and more aggressive therapy is needed. This will be very important as treatment deintensification 
for HPV+ squamous cell cancer of head and neck cancer is being evaluated.  
 
 
Positron Emission Tomography (PET) Using CCR-Based Tracers: PET imaging of 
tumor metabolism has been extensively used for staging, treatment planning and monitoring of 
response in various types of malignancies. Due to the importance of chemokine receptors, attention 
has been made to develop radiolabeled compounds that targets these receptors.  
 
 
 
64Cu-DOTA-ECL1i-PET/CT: 
Our group has developed a CCR2 specific PET radiotracer based on the peptide, ECL1i 
(d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i) 35. The CCR2 detection 
sensitivity and specificity has been demonstrated in multiple preclinical studies and ex vivo human 
tissues 36-38. We have tested this tracer in preclinical inflammation models, human pancreatic 
cancer and human head and neck cancer and demonstrated a positive correlation between the PET 
signals and CCR2 expression.  
Ex vivo characterization of 64Cu-DOTA-
ECL1i binding to CCR2 expressed in 
human head and neck cancer tissue: 
CCR2 
immunohistochemistry 
was 
performed on the de-identified human 
cancerous tonsil tissue collected from the 
SCCTPC (Figure 1A). As shown in 
Figure 1B, strong CCR2 (brown color) 
signals were detected in the area of 
tumor cells. Low CCR2 signals were 
also measured in the muscle and soft 
tissue, likely due to the expression of the 
receptors on the infiltrated macrophages 
or inflammatory cells. The control IgG 
staining showed negative signal of 
CCR2, 
confirming 
the 
specific 
expression of CCR2 on these tumor 
cells. The ex vivo binding assay of 64Cu-
DOTA-ECL1i using autoradiography 
showed strong binding to the cancerous 
area with signals in similar profile to the 
CCR2 IHC, indicating the specific 
binding of the tracer to the CCR2 
receptors on tumor cells (Figure 1C). The competitive receptor blocking using non-radiolabeled 
DOTA-ECL1i conjugate in excess amount (DOTA-ECL1i: 64Cu-DOTA-ECL1i molar ratio = 
100:1) significantly blocked the binding to the tissue. Quantitative comparison of counts in binding 
and blocking tissues demonstrated 50.8 ± 0.6% (n=4, p<0.005) blocking efficiency (Binding was 
set as 1 for each specimen), confirming the binding specificity (Figure 1D).  
 
Figure 1. Ex vivo characterization of 64Cu-DOTA-ECL1i
binding to CCR2 in human head and neck cancer tissue. 
(A) H&E. (B) CCR2 DAB staining showed high expression of 
the receptor in the area full of tumor cells. Control IgG staining 
confirmed 
the 
receptor 
staining 
specificity. 
(C)
Autoradiography showed tracer binding to the cancerous area 
of the tissue and the specificity was verified by the blocking. 
(D) Quantitative comparison of counts in binding and blocking 
tissues. 


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Summary: CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there 
is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-
targeted therapy and to monitor response to such therapy.  Our group has developed a CCR2 
specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu 
(64Cu-DOTA-ECL1i).  We also have found that 64Cu-DOTA-ECL1i specific binding has been 
demonstrated in human head and neck cancer tissue.  Currently 64Cu-DOTA-ECL1i is being 
studied in several clinical settings under IND (#137620) at Washington University.  Our group is 
studying 64Cu-DOTA-ECL1i in patients with head and neck cancer.  The use of 64Cu-DOTA-
ECL1i has proven to be safe in our ongoing clinical trials with favorable radiation dosimetry (0.064 
rem/ mCi) and is compatible with other imaging tracers such as 18F-Fludeoxyglucose (FDG) 
 
6.2.0 Objectives 
We are planning to perform a trial with goals to evaluate tumor uptake of 64Cu-DOTA-
ECL1i in patients with squamous cell head and neck cancer with at least one measurable lesion of 
≥ 1.5 cm. We also will correlate the tumor uptake of 
64Cu-DOTA-ECL1i with 
immunohistochemical staining for CCR2 receptors in the tumor specimens.  
Study objectives:  
6.2.1 To determine the diagnostic quality and CCR2 expression detection rate of 64Cu-
DOTA-ECL1i-PET/CT images.  
6.2.2 To evaluate the relationship 
between 
64Cu-DOTA-ECL1i uptake and 
immunohistochemical staining for various types of chemokine receptors such as 
CCR2.  
6.2.3  To assess the association of CCR2 expression and HPV status. CCR2 
immunohistochemical staining in HPV+ and HPV- squamous cell cancer of the 
head and neck.  To better assess the analysis of tissue prospectively we will 
retrospectively review a limited number of identified samples obtained from the 
Department of Pathology at Washington University (20 total samples).   
 
6.3.0 Statement of Qualifications  
The study will be done under eIND (#137620).  Robert J. Gropler, M.D., Washington 
University School of Medicine, St. Louis, Missouri is the physician-investigator of the IND.  
 
6.4.0 Inclusion Criteria/ Exclusion Criteria 
Adult patients (men or women) with confirmed new diagnosis of squamous cell head and 
neck cancer who are being evaluated for surgical resection or definitive therapy  are eligible 
to participate in this study.   
 
Inclusion Criteria:  
• Adult patient 18 years of age or older 
• Cytology or biopsy-proven squamous cell head and neck cancer scheduled to be treated 
with standard of care surgery. Patients who are not surgical candidates should have 
adequate tissue from tumor biopsy for analysis of CCR2.  
•  Lesion size of at least 1.5 cm (treatment naïve)  
• Able to give informed consent 
• Not currently pregnant or nursing:  Subject must be surgically sterile (has had a 
documented bilateral oophorectomy and/or documented hysterectomy), post-
menopausal (cessation of menses for more than 1 year), non-lactating, or of 


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childbearing potential for whom a urine pregnancy test (with the test performed within 
the 24 hour period immediately prior to administration of 64Cu-DOTA-ECL1i is 
negative  
 
Exclusion Criteria: 
• Patients with other invasive malignancies, with the exception of non-melanoma skin 
cancer, who had (or have) any evidence of the other cancer present within the last 2 
years 
• Unable to tolerate approximately 90 min (total time) of PET/CT imaging. 
 
6.4.1 Inclusion of Women and Minorities 
Both men and women are eligible. Members of all races and ethnic groups are 
eligible for this trial. 
 
6.4.2 Registration Procedures & Screen Failures 
Initial eligibility will be confirmed by the study coordinator.  The PI, Co-PI or other 
engaged study investigator will review and sign an eligibility checklist to confirm 
the patient is eligible to participate on study.  All enrolled subjects will be given a 
unique study specific patient identification and registered through the Siteman 
Cancer Center OnCore database at Washington University.  Screen failures are 
those subjects who consent to and undergo any study related procedures.  A subject 
who signs consent in clinic but declines to participate after further discussion of the 
imaging protocol and study requirements with the study coordinator is not 
considered a screen failure and will not be registered to the protocol since no study 
procedures took place.   
 
 
6.5.0 METHODS  
6.5.1 Study Design  
A single center, open-label, baseline-controlled diagnostic imaging study designed to 
assess the diagnostic quality and CCR2 expression detectability of 64Cu-DOTA-ECL1i 
imaging with PET/CT. In addition, data will be collected to build the ongoing safety 
profile of 64Cu-DOTA-ECL1i and uptake will be correlated to in vitro assays of 
chemokines receptor from clinically obtained biopsy/surgical specimen. 
     
6.5.2 Patient Population  
Twenty adult individuals with new diagnosis of squamous cell of the head and neck 
cancer who are scheduled for definitive therapy (surgery for fresh tissue collection or 
other standard of care therapy who have  adequate tissue from tumor biopsy for analysis 
of CCR2) and have not received treatment for their cancer will be studied.  Written 
informed consent will be obtained prior to the PET imaging session.  64Cu-DOTA-
ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the 
known tumor followed by a limited body scan of the head/neck and upper chest will be 
performed in each patient.  64Cu-DOTA-ECL1i -PET/CT images will also be correlated 
with all available imaging studies to assess lesion localization.   
 


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12 
To aid prospective tissue analysis a total of 20 samples (10 each: HPV+ and HPV-) 
will be obtained from the Department of Pathology at Washington University and 
immunohistochemical staining of CCR2 will be performed.  
 
6.5.3 PET Imaging  
All subjects will have a minimum of 24 hours to review the consent form before 
agreeing to participate in this research project. All PET imaging will be performed with 
a PET/CT scanner with preference given to scanners located in the Center for Clinical 
Imaging Research Center (CCIR) located on the 10th floor West Pavilion of Barnes-
Jewish Hospital.   
 
All patients will undergo routine clinical staging as dictated by the treating physician. 
The results of 64Cu-DOTA-ECL1i-PET/CT will not be provided to the patient or the 
treating oncologist/surgeon unless, in the judgment of the principal investigator, the 
images demonstrate an unsuspected abnormality that may warrant further evaluation.  
 
Serum Stability and Metabolite Analysis (whenever possible): 64Cu-DOTA-ECL1i has 
been shown to be stable up to 60 min in preclinical studies.   Our preclinical studies 
showed 95% of the tracer was intact after 1 hour incubation with mouse serum. In order 
to assess serum stability and for metabolite analysis of 64Cu-DOTA-ECL1i in this 
patient population, 2 venous samples (approximately 1 mL each) will be obtained (1 
within the first 5 min of imaging and 1 at the completion of the first hour of imaging). 
Additional blood samples may be obtained based on results of the 2 samples to increase 
the time points, if necessary. 
 
For each PET/CT study, when collected, high performance liquid chromatography 
(HPLC) analysis of the serum stability and metabolite profile will be performed by Dr. 
Liu Lab 37,38. Whole blood will be centrifuged; plasma and packed red cells will be 
separated and the radioactivity in each portion will be recorded.  A 200 µL aliquot of 
plasma will be diluted with 200 µL MilliQ water and passed through a 0.22 micron 
filter prior to HPLC injection.  Eluent fractions will be collected every 1 minute and 
analyzed by gamma counting.     
 
6.5.3.1 PET Imaging Procedure 
Following administration of 8-10 mCi of the radiotracer 64Cu-DOTA-
ECL1i-PET/CT, all twenty subjects who enter on study will undergo a 60 minute 
dynamic scan centered over the site of the known tumor.  An additional limited 
scan (top of head to upper/mid-chest) will be performed approximately 1-3 hours 
after administration. 
 
For dynamic imaging, the subject will be placed supine on the imaging table with 
arms secured comfortably by the side of the body.  A low dose spiral CT scan for 
attenuation correction will be obtained centered on the primary tumor site.  The CT 
will consist of a 5-20 second topogram for determining correct anatomical 
positioning followed by a spiral CT at a maximum of 50 mAs. Care dose will be 
calculated for each scan and the care dose imaging parameters will be used if less 
than the maximum 50 mAs is calculated. CT imaging will be acquired with a 
standard 120 kVp. Average spiral CT scan time is 5-30 seconds. Scans are acquired 


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13 
using a 3-5 mm slice thickness.  Immediately after the attenuation CT scan, subjects 
will be injected with 8 – 10 mCi 64Cu-DOTA-ECL1i .  The dose will be followed 
with a normal saline flush of 10-30 ml. A 60 min list mode dynamic imaging 
acquisition will follow study drug injection.  At the end of the imaging session, 
subjects will be encouraged to void.     
 
Subjects will be allowed to rest outside of the scanner until such time subject 
indicates they are willing to start the 2nd scan (1 – 3 hours post injection).  Scan #2 
will consist of a limited body scan from the vertex to upper/mid chest region.  
Following topogram and low dose CT scan for attenuation correction (maximum 
50 mAs with care dose imaging parameters) a 2 bed limited scan from vertex to 
upper / mid chest will be obtained at 3-5 minutes per bed position.     
To add to the existing safety profile of 64Cu-DOTA-ECL1i,  all subjects will 
undergo vital sign measurement, clinical laboratory testing, and ECG testing as 
specified in sections 6.5.5, 6.5.6 and 6.5.7 of the protocol.   
 
6.5.4 PET Image Processing and Analysis  
List mode dynamic PET images will be reconstructed using current scanner 
manufacturer recommendations as follows (frames x seconds) 12x10, 6x30, and 11x300.  
PET images will be evaluated qualitatively (graded on a five-point scale regarding the 
presence or absence of abnormal uptake: 1 = definitely negative; 2 = probably negative; 3 
= equivocal; 4 = probably positive; and 5 = definitely positive) and then, semi-
quantitatively (standardized uptake value (SUV), tumor-to-normal tissue ratio (T/N) or 
tumor-muscle-ratio (T/M)) with the knowledge of the location (correlating with all 
available imaging studies). SUV is a decay-corrected measurement of activity per volume 
of tissue (µCi/mL) divided by the average activity per unit mass in the entire body. The 
overall PET image quality also will be graded (using 4-point scale with 1 being the worse 
and poor quality, not acceptable for diagnostic interpretation and 4 being good image 
quality, similar to routine clinical studies. PET analysis will not be performed in real time, 
but performed in batches or after all subjects have been enrolled, however, the images will 
be evaluated qualitatively for incidental findings.   
The pharmacokinetic of the lesion time-activity curve using graphical analysis and 
tracer kinetic compartmental modeling will be determined.  Classical receptor-ligand 
models will be employed to describe the kinetics of the tracers and different models to 
optimize goodness-of-fit will be evaluated.  Goodness-of-fit will be judged by a nested F-
test for the number of parameters, Akaike Information Criterion (AIC), and the Schwarz 
Criteria.1-tissue with two kinetic rate constants and 2-tissue with 4 rate constants 
compartmental reversible models will be used to fit the data using the blood input function 
as input function.  The blood time activity curve will be determined noninvasively from a 
large 3D ROI traced over the aorta (OR carotid artery) and corrected for metabolites per 
above analyses, if available.  The measured lesion time-activity curves will be fitted to the 
1- or 2-compartment model prediction and added to the plasma component weighted by 
the tissue blood fraction Vb.  Best fit will be used to determine the distribution volume 
(DV) from the 1-tissue model (with DV = K1/k2), and we will determine the DV and the 
non-displaceable binding potential (BP) from the 2-tissue model (with DV = (K1/k2)(1+BP) 
and BP = k3/k4).  The graphical analysis using Logan and Patlak analysis to determine the 
volume of distribution (DV) also will be performed. We will further use both the plasma 
time activity curve and a reference region to determined DV and DVR, respectively with 
non-displaceable BP = DVR -1.  A possible region of reference will be a suitably located 


Version #5 08/28/2023 
 
14 
muscle in the same field of view as head and neck cancer. All quantitative and semi-
quantitative metrics of 64Cu-DOTA-ECL1i-PET/CT will be correlated with CCR2 receptor 
expression and binding affinity of each biopsy-proven tumor specimen.   
 
6.5.5 Vital Signs 
All vital signs will be recorded on the case report form. Vital signs may be obtained 
with the subject in the supine or upright position. Care will be taken to obtain subsequent 
recordings with the subject in the same position (supine or upright). Although allergic or 
other immediate adverse reactions are not anticipated, subjects will be monitored for at 
least 60 min post injection. Vital signs will be obtained at 3 time points pre-injection 
(anticipated to be within 30 mins prior to injection of 64Cu-DOTA-ECL1i although it might 
be longer if delays in quality control testing result in delay of study drug injection), at the 
completion of dynamic imaging and at study discharge.    Vital signs will include the 
following: heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, and 
body temperature. The following changes from baseline will be considered noteworthy:   
 
Heart rate: 
 
 
> 30 beats per min 
 
Systolic blood pressure 
> 40 mm Hg 
 
Diastolic blood pressure 
> 30 mm Hg 
Noteworthy changes will be documented on the Principal Investigator Data Safety 
Review Form. The Principal Investigator will indicate on the form whether or not the 
changes in vital signs are clinically significant. If clinically significant, the principal 
investigator will assess the causality of the change to the injection of 64Cu-DOTA-ECL1i.. 
If a clinically significant change of a vital sign is noted and assessed as being attributable 
to 64Cu-DOTA-ECL1i injection by the Principal Investigator on the Data Safety and 
Review CRF, it will be reported on the adverse event log.  
 
6.5.6 Clinical Laboratory Testing 
Laboratory tests will consist of the following: standard CBC, and comprehensive 
metabolic panel obtained at the following time points:  
• Baseline: 
Baseline labs may be obtained anytime within 21 days or 
immediately prior to 64Cu-DOTA-ECL1i injection and can be done as 
standard of care or for research purposes.   
• Discharge: At least 60 minutes post injection or prior to study discharge.   
Approximately 15 mL of blood will be collected for clinical laboratory testing, serum stability 
/ metabolite analysis.     
 
Labs obtained at baseline prior to injection of 64Cu-DOTA-ECL1i will be compared to labs 
obtained at study discharge.  The following changes from baseline clinical laboratory values 
are considered to be noteworthy and require assessment as to clinical significance when they 
fall outside of normal limits. Clinically significant changes in laboratory values which are 
attributed to 64Cu-DOTA-ECL1i injection should be followed up until they return to baseline 
or normal levels, or until follow-up is no longer warranted. Laboratory values that are abnormal 
at baseline but move into normal range will not be considered clinically significant.  If a 
clinically significant change of a laboratory value is noted, it will be reported on the PI Data 
Safety and Review Form so that the PI can assess the change as being attributable to 64Cu-
DOTA-ECL1i injection.  All clinically significant laboratory changes as identified below 


Version #5 08/28/2023 
 
15 
which are identified by the PI as being attributable to 64Cu-DOTA-ECL1i will be recorded on 
the adverse event log.   
Clinically Significant Laboratory Values 
Analyte 
Change from baseline 
Hemoglobin 
> 2g/dL 
WBCs 
> 1 K/mm3 
Neutrophils  
> 10 % 
Lymphocytes  
> 10% 
Platelets 
> 50 K/mm3 
Creatinine 
> 0.75 mg/dL 
BUN 
> 20 mg/dL 
Calcium 
> 1mg/dL 
Sodium 
> 5 mmol//L 
Potassium 
> 0.5 mmol/L 
CO2 
> 4 mmol/L 
ALT (SGPT)  
> 150 IU/L 
AST (SGOT) 
> 100 IU/L 
Alkaline Phosphatase 
> 150 IU/L 
Total Bilirubin 
> 0.5 mg/dL 
Albumin  
> 1g/dL 
 
6.5.7 Electrocardiograms (ECGs)  
A standard 12-lead ECG will be obtained on all subjects at baseline (within 
approximately 30 mins prior to injection of 64Cu-DOTA-ECL1i although it might be 
longer if delays in quality control testing result in delay of study drug injection), and at 
least 60 minutes post injection or prior to study discharge.    
The following table lists criteria for normal limits and clinically notable limits 
for ECGs in adults.  
 
Criteria for Normal Limits and Clinically Notable Limits for ECGs in Adults 
 
Normal Limits (msec) 
Notable Limits (msec) 
ECG Variables 
Low 
High 
Low  
High 
PR interval 
120 
200 
<120 
>200 
QRS interval 
50 
100 
< 50 
>100 
RR interval 
600 
1000 
<600 
>1000 
QT interval 
No lower limit 
≥ 460 
No lower limit 
≥ 460 


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16 
ECG’s which have limits noted to be outside of the table above will be recorded on the PI Data 
Safety and Review Form where the PI will review and assess as being attributable to 64Cu-DOTA-
ECL1i injection.  Any ECG recordings identified by the PI as being attributable to 64Cu-DOTA-
ECL1i  will be recorded on the adverse event log. 
 
6.5.8 Safety & Clinical Follow-Up 
 
To continue collecting data for the safety profile of 64Cu-DOTA-ECL1i a follow up phone 
call or in person visit to assess for adverse events will occur at least 24 hours following 
administration of 64Cu-DOTA-EL1i.  Taking into consideration both the physical half-life (13 
hours) and the much quicker biological half-life optimal follow up time is 48-120 hours post 
injection but follow up as soon as 24 hours and as late as 14 days post administration are allowed.  
As this is a verbal secondary assessment follow up phone call or visit beyond 14 days will be 
accepted with proper documentation of delay(s) such as subject underwent surgical resection and 
unavailable due to surgery and subsequent recovery.  It is anticipated that some subjects may be 
scheduled for surgery as soon as 12 hours following 64Cu-DOTA-ECL1i administration and 
imaging so care will be taken to separate surgical related signs and symptoms from those which 
might be attributed to 64Cu-DOTA-ECL1i administration and PET/CT imaging.   
 
Clinically, subject’s medical record will be followed to document surgical resection or the start of 
definitive therapy.   
 
 
6.5.9 Immunohistochemical Evaluation of Chemokinetic Receptors 
To evaluate the relationship between 64Cu-DOTA-ECL1i uptake and expression of CCR2 
receptors in head and neck tumor samples, IHC staining in all patients who have available tissue 
will be performed using techniques routinely performed in Dr. Liu’s Laboratory 37,38. Intensity of 
CCR2 signal in IHC will be assessed by study pathologist, Dr. Chernock and categorized into 4 
categories (0=absent/faint, 1=weak, 2=moderate, 3=strong). Any cells that stained positively with 
CCR2 will be assessed and the final score will be based on an overall assessment of CCR2 IHC 
on all these cells.  It is anticipated that most subjects will have tumor available from planned 
surgical resection or prior biopsy however standard of care clinical analysis of resected tumor will 
take priority over research tissue testing.  Tumor testing will occur in batches or at the end of study 
recruitment depending on availability of testing supplies.   
To better understand how CCR2 expression correlates with HPV status and to correlate 
with samples obtained prospectively a small retrospective tissue analysis study will also be 
performed.  We will obtain tissue from 10 HPV+ and 10 HPV- squamous cell head and neck cancer 
subjects from the Department of Pathology at Washington University.  These samples will be 
analyzed, as described above, to establish baseline expectations on the correlation of CCR2 
expression to HPV status.   
  
 
6.6.0 Drug Preparation  
64CuCl2 will be produced by the Cyclotron Facility at Washington University School of 
Medicine, Mallinckrodt Institute of Radiology. 64Cu-DOTA-ECL1i will be produced in the 
Biologic Therapy Core Facility (ISO 7, class 10,000) at Washington University School of 
Medicine following SOPs and batch production records. To produce 64Cu-DOTA-ECL1i, 
64CuCl2 (20-70 mCi) will be buffered with 20 mM sodium acetate stabilized with gentisic acid 
and then added to DOTA-ECL1i (30 μg) to bring the total volume to 500 μL (we do not expect 
any interference with CCR2/5 inhibitor therapeutic effect, because we use a trace amount of 


Version #5 08/28/2023 
 
17 
DOTA-ECL1i in comparison to 600 mg therapeutic dose, which is 20,000 higher than the 
imaging dose). This reaction is incubated in a 45ºC heated shaker (ThermoMixer, Eppendorf) 
for 45 minutes at 950 rpm during which time the DOTA chelator binds with 64Cu. The product 
will be evaluated by pre-release specifications and post-release specifications to control the 
quality of the radiotracer for clinical study. This study will be done under an eIND (#137620) 
for 64Cu-DOTA-ECL1i 
 
6.7.0 Statistics  
Demographic and clinical characteristics of the enrolled patients will be summarized using 
descriptive statistics with frequency and percentages used for categorical variables, median (25th, 
75th) for ordinal variables and mean (standard deviation) for continuous variables. The diagnostic 
quality of images and CCR2 expression detection will be assessed qualitatively and semi-
quantitatively for all participants and these measures (described above) will be summarized for a 
lesion using descriptive statistics. The association between 64Cu-DOTA-ECL1i uptake and tissue 
signal intensity for CCR2 and other chemokine receptors will be evaluated using a Spearman 
correlation coefficient. Collection of additional data for the safety profile will not undergo formal 
statistical review.    
The primary goal of this single center, open-label, baseline-controlled diagnostic imaging 
study is to assess the diagnostic quality and CCR2 expression detectability of 64Cu-DOTA-ECL1i 
in head and neck cancer patients. The study is primarily descriptive and the sample size is based 
on feasibility of recruitment. However, a sample size of 20 achieves 80% power to detect a 
correlation of 0.61 using a two-sided hypothesis test with a significance level of 0.05.  
 
6.8.0 Risks and Benefits 
Targeting CCR2 is emerging as a promising therapeutic strategy in many types of cancer, 
but accurate patient selection for this strategy is critical. The potential risks from this imaging 
protocol are expected to be very low. Expected risks include discomfort from the placement of 
intravenous catheter(s) for injection of 64Cu-DOTA-ECL1i, radiation exposure from the injection 
of 64Cu-DOTA-ECL1i and CT for attenuation correction scans, and discomfort from lying still on 
the imaging table. A temporary altered taste sensation may be associated with the IV injection of  
64Cu-DOTA-ECL1i.   Blood samples will be obtained for safety profile, whenever possible 
additional samples are collected for serum stability and metabolites testing.  There is a slight risk 
of bruising and a remote risk of infection from the placement of the intravenous catheter(s).  
Although unlikely, there is a rare chance of having patients suffer an allergic or other immediate 
adverse reaction to 64Cu-DOTA-ECL1i.  To minimize the risks to subjects, intravenous catheters 
will only be placed by trained personnel. All studies will take place under the supervision of the 
Principal Investigator or a collaborating physician. Additionally, the PET scanner is located within 
the hospital where advanced life support personnel and equipment are available for immediate use.  
Radiation Exposure: This research project involves radiation exposure to participants from 
the i.v. injection of 64Cu-DOTA-ECL1i. The total amount of radiation exposure received from one 
10 mCi injection is 0.64 rem.  Additional radiation exposure from 2 CT scans for attenuation 
correction will result in an additional 0.27 rem of exposure (including dose from positioning 
topogram – 0.09 rem from 1 bed dynamic scan + 0.18 rem from 2 bed limited scan)  Total radiation 
exposure from one 10 mCi injection of 64Cu-DOTA-ECL1i and 2 limited low dose CT scans for 
attenuation correction is 0.91 rems or approximately 18% of the annual dose for a radiation worker.   
The patients entered on this study will not directly benefit from 64Cu-DOTA-ECL1i-
PET/CT imaging, the overall and long-term benefits to future patients with head and neck cancer 
far outweigh the minimal risks anticipated.  The minimal risks should be far outweighed by the 


Version #5 08/28/2023 
 
18 
potential benefit to society.  It is anticipated that this study will contribute to the understanding of 
the performance of the 64Cu-DOTA-ECL1i-PET/CT in evaluating CCR2 expression in head and 
neck cancers that will have important impact on the selection of the patients for appropriate mode 
of therapy.  Ultimately, 
64Cu-DOTA-ECL1i-PET/CT may provide clinically important 
information to predict/assess the effectiveness of CCR2-targeted therapy.   
The results of the PET imaging studies to be performed as part of the proposed research 
are not intended to be used in the diagnostic evaluation or treatment planning of individual patients.  
The results of the PET studies will not be provided to the patient or the treating oncologist or 
surgeon unless the CT images demonstrate an unsuspected, potentially life-threatening 
abnormality that warrants further investigation and/or urgent therapy.  Dr. Dehdashti will assess 
all imaging results in light of other clinical and radiologic data and will inform the responsible 
attending physician as soon as possible if the information derived from the experimental imaging 
studies is judged to be of critical importance to the care of individual patients. 
 
6.9.0 Record Keeping 
It is anticipated that 20 subjects will be entered into this study. Initial review of images for 
quality and uptake will occur in real time with additional analysis performed in batches or after 
enrollment has been completed.  The pathological analysis of the CCR2 will be performed after 
study enrollment has been completed on the standard of care specimens obtained at surgical 
resection or from diagnostic biopsy. Data collected to ensure the safety profile of 64Cu-DOTA-
ECL1i is accurate will be assessed from the time prior to study drug injection through imaging 
discharge.   
 A patient file will be kept in the Research Coordinators’ suite located on the 10th floor of 
the Mallinckrodt Institute of Radiology in Barnes-Jewish Hospital South Campus. All digital data 
associated with 64Cu-DOTA-ECL1i-PET/CT is maintained on the PET acquisition computer. Raw 
data files are backed up on password protected encrypted external hard drive(s). All imaging data 
may also backed up on DVD after it has been transferred to a desktop PC. Processed data will be 
stored on the Principal Investigator's password protected desktop.  CRF's and patient files will be 
stored in the study coordinators' office. Entrance to the PI's and coordinators' offices requires 
admission through two separate locked doors.  Standard laboratory assessment (CBC + CMP) will 
be processed locally with results added to the subjects electronic medical record.  ECG’s are 
obtained for study purposes only and are not included in the electronic medical record.   
 
 
6.10.0 Regulatory and Reporting Requirements   
 
The entities providing oversight of safety and compliance with the protocol require reporting as 
outline below.  Please refer to Appendix A for definitions and Appendix B for grid of reporting 
timelines.  Adverse events will be tracked from start of treatment through study discharge.  All 
adverse events must be recorded on the toxicity tracking case report form (CRF) with the 
exception of: 
• 
Baseline adverse events, which shall be recorded on the appropriate study CRF 
• 
Events related to surgery or any testing or procedures performed in preparation for 
surgery 
 
Reporting requirements for Washington University study team may be found in Section 6.10.1   
 


Version #5 08/28/2023 
 
19 
6.10.1 Sponsor – Investigator / WU PI Reporting Requirements  
6.10.1.1 Reporting to the Human Research Protection Office (HRPO) at Washington 
University) 
Reporting will be conducted in accordance with Washington University IRB Policies. 
 
Pre-approval of all protocol exceptions unless they meet the definition of unforeseen 
imaging exception as described in Appendix A must be obtained prior to implementing 
the change.   
 
6.10.1.2 Reporting to the Quality Assurance and Safety Monitoring Committee (QASMC) at 
Washington University 
The Washington University Sponsor Investigator / PI (or designee) is required to 
notify the QASMC of any unanticipated problems involving risks to participants or 
others occurring at WU or any BJH or SLCH institution that have been reported to 
and acknowledged by HRPO.  (Unanticipated problems reported to HRPO and 
withdrawn during the review process need not be reported to QASMC.) 
 
QASMC must be notified within 10 days of receipt of IRB acknowledgment via 
email to qasmc@wustl.edu.  Submission to QASMC must include the myIRB form 
and any supporting documentation sent with the form. 
 
 
6.10.1.3 Reporting to the FDA 
The conduct of the study will comply with all FDA safety reporting requirements.  PLEASE 
NOTE THAT REPORTING REQUIREMENTS FOR THE FDA DIFFER FROM REPORTING 
REQUIREMENTS FOR HRPO/QASMC.  It is the responsibility of the Washington University 
principal investigator to report to the FDA as follows: 
 
• 
Report any unexpected fatal or life-threatening suspected adverse reaction (refer to Appendix 
A for definitions) no later than 7 calendar days after initial receipt of the information.   
• 
Report a suspected adverse reaction that is both serious and unexpected (SUSAR, refer to 
Appendix A) no later than 15 calendar days after it is determined that the information 
qualifies for reporting.  Report an adverse event (refer to Appendix A) as a suspected adverse 
reaction only if there is evidence to suggest a causal relationship between the drug and the 
adverse event, such as: 
o A single occurrence of an event that is uncommon and known to be strongly associated 
with drug exposure 
o One or more occurrences of an event that is not commonly associated with drug exposure 
but is otherwise uncommon in the population exposed to the drug 
o An aggregate analysis of specific events observed in a clinical trial that indicates those 
events occur more frequently in the drug treatment group than in a concurrent or 
historical control group 
• 
Report any findings from epidemiological studies, pooled analysis of multiple studies, or 
clinical studies that suggest a significant risk in humans exposed to the drug no later than 15 
calendar days after it is determined that the information qualifies for reporting. 
• 
Report any findings from animal or in vitro testing that suggest significant risk in humans 
exposed to the drug no later than 15 calendar days after it is determined that the information 
qualifies for reporting.  


Version #5 08/28/2023 
 
20 
• 
Report any clinically important increase in the rate of a serious suspected adverse reaction of 
that listed in the protocol or IB within 15 calendar days after it is determined that the 
information qualifies for reporting. 
 
Submit each report as an IND safety report in a narrative format or on FDA Form 3500A or in an 
electronic format that FDA can process, review, and archive.  Study teams must notify the 
Siteman Cancer Center Protocol Development team of each potentially reportable event within 1 
business day after initial receipt of the information, and must bring the signed 1571 and FDA 
Form 3500A to the Siteman Cancer Center Protocol Development team no later than 1 business 
day prior to the due date for reporting to the FDA. 
 
Each notification to FDA must bear prominent identification of its contents (“IND Safety 
Report”) and must be transmitted to the review division in the Center for Drug Evaluation and 
Research (CDER) or in the Center for Biologics Evaluation and Research (CBER) that has 
responsibility for review of the IND.  Relevant follow-up information to an IND safety report 
must be submitted as soon as the information is available and must be identified as such 
(“Follow-up IND Safety Report”). 
 
 
6.10.2 Exceptions to Expedited Reporting 
Events that do not require expedited reporting as described in Section 1.1 include: 
• 
planned hospitalizations 
• 
hospitalizations < 24 hours 
• 
respite care 
• 
events related to disease progression 
• Unforeseen imaging exceptions as described in Appendix A 
Events that do not require expedited reporting must still be captured in the study files/ 
case report forms.   
 
6.11.0 Data and Safety Monitoring 
 
In compliance with the Washington University Institutional Data and Safety Monitoring Plan, 
the Principal Investigator will provide a Data and Safety Monitoring (DSM) report to the 
Washington University Quality Assurance and Safety Monitoring Committee (QASMC) semi-
annually beginning six months after accrual has opened (if at least one patient has been enrolled) 
or one year after accrual has opened (if no patients have been enrolled at the six-month mark). 
 
For imaging studies, the Principal Investigator will review all patient data at least every six 
months, and provide a semi-annual report to the QASMC. This report will include: 
• 
HRPO protocol number, protocol title, Principal Investigator name, data coordinator 
name, regulatory coordinator name, and statistician 
• 
Date of initial HRPO approval, date of most recent consent HRPO approval/revision, date 
of HRPO expiration, date of most recent QA audit, study status, and phase of study 
• 
History of study including summary of substantive amendments; summary of accrual 
suspensions including start/stop dates and reason; and summary of protocol exceptions, 
error, or breach of confidentiality including start/stop dates and reason 
• 
Study-wide target accrual and study-wide actual accrual 
• 
Protocol activation date 


Version #5 08/28/2023 
 
21 
• 
Average rate of accrual observed in year 1, year 2, and subsequent years 
• 
Expected accrual end date and accrual by cohort 
• 
Objectives of protocol with supporting data and list the number of participants who have 
met each objective 
• 
Measures of efficacy (phase I studies only if efficacy is objective of the protocol) 
• 
Early stopping rules with supporting data and list the number of participants who have 
met the early stopping rules 
• 
Power analysis and/or interim analysis (if described in the protocol) 
• 
Summary of toxicities separated by cohorts with the number of dose-limiting toxicities 
indicated 
• 
Abstract submissions/publications 
• 
Summary of any recent literature that may affect the safety or ethics of the study  
 
The study principal investigator and Research Patient Coordinator will monitor for serious 
toxicities on an ongoing basis. Once the principal investigator or Research Patient Coordinator 
becomes aware of an adverse event, the AE will be reported to the HRPO and QASMC 
according to institutional guidelines. 
 
6.12.0 Data Submission Schedule  
 
Case report forms with appropriate source documentation will be completed according to the 
schedule listed in this section. 
 
Case Report Form 
Submission Schedule 
Eligibility check List 
Prior to registration  
Original Consent Form 
Prior to registration 
PET Imaging Form  
Real Time completion of events as they occur 
PET Imaging Follow up 
Form 
Real time to comply with protocol requirements 
Adverse Event Log  
After follow up has been completed  
PI Data Safety Review 
After follow up and AE forms have been completed  
Tissue Collection Form  
At time of surgery or requested after follow up from 
standard of care biopsy sample  
Image Analysis Form  
Per PI Schedule  
 
 
 


Version #5 08/28/2023 
 
22 
6.13 
Study Calendar  
 
Procedure 
Baseline(a) 
Imaging(b) 
Follow up 
Phone 
Call/Visit (d) 
Tissue 
Collection  
Informed Consent 
X 
 
 
 
Medical History 
X 
 
 
 
Radiology Reports 
X 
 
 
 
Pathology Report(s) 
X 
 
 
 
Blood for Laboratory/ 
Serum Stability & 
Metabolite Analysis  
X(c) 
X 
 
 
Vital Signs(d) 
X 
X 
 
 
ECG(e) 
X 
X 
 
 
PET/CT Imaging  
 
X 
 
 
AE Assessment  
X 
X 
X 
 
SOC Tissue Collection (f) 
 
 
 
X 
(a) Baseline is defined as period from initial subject consent until injection of 64Cu-
DOTA-ECL1i Baseline for vital signs and ECG is within approximately 30 mins prior 
to injection of 64Cu-DOTA-ECL1i.  Baseline blood for laboratory samples is within 21 
days up to immediately prior to 64Cu-DOTA-EL1i administration.  
(b) Imaging day is defined as period of time from injection of 64Cu-DOTA-ECLi1 
through completion of imaging on that day.   
(c) Baseline lab is CBC/CMP prior to study drug injection.  Serum Stability /Metabolite 
samples are drawn post injection and post scan #1 whenever possible.  Discharge labs 
are repeat CBC/CMP drawn at least 60 minutes post injection.   
(d) Follow up will occur at least 24 hours following administration of 64Cu-DOTA-
ECL1i optimal follow up time is 48-120 hours however follow up as soon as 24 hours 
and as late as 14 days is acceptable.   
(e) To be performed prior to and at least 60 min after administration of 64Cu-DOTA-
ECL1i.   
(f) Fresh tissue is collect at the time of surgical resection.  If other therapy is planned 
tissue or slides will be requested from standard of care biopsy samples. 
 
 


Version #5 08/28/2023 
 
23 
6.14 
References 
 
 
1. 
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2. 
Zlotnik A, Yoshie O, Nomiyama H: The chemokine and chemokine receptor 
superfamilies and their molecular evolution. Genome Biol 7:243, 2006 
 
3. 
Allen SJ, Crown SE, Handel TM: Chemokine: receptor structure, interactions, and 
antagonism. Annu Rev Immunol 25:787-820, 2007 
 
4. 
Wang JH, Wang JC, Sun YX, et al: Diverse signaling pathways through the SDF-
1/CXCR4 chemokine axis in prostate cancer cell lines leads to altered patterns of cytokine 
secretion and angiogenesis. Cell Signal 17:1578-1592, 2005 
 
5. 
Engl T, Relja B, Blumenberg C, et al: Prostate tumor CXC-chemokine profile 
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6. 
Chinni SR, Yamamoto H, Dong Z, et al: CXCL12/CXCR4 transactivates HER2 in 
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7. 
Rajagopal S, Kim J, Ahn S, et al: Beta-arrestin- but not G protein-mediated 
signaling by the "decoy" receptor CXCR7. Proc Natl Acad Sci U S A 107:628-32, 2010 
 
8. 
Singh RK, Lokeshwar BL: The IL-8-regulated chemokine receptor CXCR7 
stimulates EGFR signaling to promote prostate cancer growth. Cancer Res 71:3268-77, 2011 
 
9. 
Mustafa S, See HB, Seeber RM, et al: Identification and profiling of novel alpha1A-
adrenoceptor-CXC chemokine receptor 2 heteromer. J Biol Chem 287:12952-65, 2012 
 
10. 
Wang J, Xi L, Gooding W, et al: Chemokine receptors 6 and 7 identify a metastatic 
expression pattern in squamous cell carcinoma of the head and neck. Adv Otorhinolaryngol 
62:121-33, 2005 
 
11. 
da Silva JM, das Neves Azevedo A, dos Santos Barbosa RP, et al: Dynamics of 
murine B lymphocytes is modulated by in vivo treatment with steroid ouabain. Immunobiology 
221:368-76, 2016 
 
12. 
Singh S, Singh UP, Stiles JK, et al: Expression and functional role of CCR9 in 
prostate cancer cell migration and invasion. Clin Cancer Res 10:8743-50, 2004 
 
13. 
Heresi GA, Wang J, Taichman R, et al: Expression of the chemokine receptor 
CCR7 in prostate cancer presenting with generalized lymphadenopathy: report of a case, review 
of the literature, and analysis of chemokine receptor expression. Urol Oncol 23:261-7, 2005 
 
14. 
Murphy C, McGurk M, Pettigrew J, et al: Nonapical and cytoplasmic expression of 
interleukin-8, CXCR1, and CXCR2 correlates with cell proliferation and microvessel density in 
prostate cancer. Clin Cancer Res 11:4117-27, 2005 
 
15. 
Waugh DJ, Wilson C: The interleukin-8 pathway in cancer. Clin Cancer Res 
14:6735-41, 2008 
 
16. 
Sekula M, Miekus K, Majka M: Downregulation of the CXCR4 receptor inhibits 
cervical carcinoma metastatic behavior in vitro and in vivo. Int J Oncol 44:1853-60, 2014 
 
17. 
Schrevel M, Karim R, ter Haar NT, et al: CXCR7 expression is associated with 
disease-free and disease-specific survival in cervical cancer patients. Br J Cancer 106:1520-5, 
2012 
 
18. 
Nayak TR, Hong H, Zhang Y, et al: Multimodality imaging of CXCR4 in cancer: 
current status towards clinical translation. Curr Mol Med 13:1538-48, 2013 
 
19. 
Yoon Y, Liang Z, Zhang X, et al: CXC chemokine receptor-4 antagonist blocks 
both growth of primary tumor and metastasis of head and neck cancer in xenograft mouse models. 
Cancer Res 67:7518-24, 2007 
 
20. 
Li JK, Yu L, Shen Y, et al: Inhibition of CXCR4 activity with AMD3100 decreases 
invasion of human colorectal cancer cells in vitro. World J Gastroenterol 14:2308-13, 2008 


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21. 
Zeng Z, Samudio IJ, Munsell M, et al: Inhibition of CXCR4 with the novel RCP168 
peptide overcomes stroma-mediated chemoresistance in chronic and acute leukemias. Mol Cancer 
Ther 5:3113-21, 2006 
 
22. 
Oda Y, Tateishi N, Matono H, et al: Chemokine receptor CXCR4 expression is 
correlated with VEGF expression and poor survival in soft-tissue sarcoma. Int J Cancer 124:1852-
9, 2009 
 
23. 
Han L, Jiang B, Wu H, et al: High expression of CXCR2 is associated with 
tumorigenesis, progression, and prognosis of laryngeal squamous cell carcinoma. Med Oncol 
29:2466-72, 2012 
 
24. 
Tan CT, Chu CY, Lu YC, et al: CXCL12/CXCR4 promotes laryngeal and 
hypopharyngeal squamous cell carcinoma metastasis through MMP-13-dependent invasion via the 
ERK1/2/AP-1 pathway. Carcinogenesis 29:1519-27, 2008 
 
25. 
Rehman AO, Wang CY: CXCL12/SDF-1 alpha activates NF-kappaB and promotes 
oral cancer invasion through the Carma3/Bcl10/Malt1 complex. Int J Oral Sci 1:105-18, 2009 
 
26. 
Wang N, Wu QL, Fang Y, et al: Expression of chemokine receptor CXCR4 in 
nasopharyngeal carcinoma: pattern of expression and correlation with clinical outcome. J Transl 
Med 3:26, 2005 
 
27. 
Ueda M, Shimada T, Goto Y, et al: Expression of CC-chemokine receptor 7 
(CCR7) and CXC-chemokine receptor 4 (CXCR4) in head and neck squamous cell carcinoma. 
Auris Nasus Larynx 37:488-95, 2010 
 
28. 
Chen MK, Yeh KT, Chiou HL, et al: CCR2-64I gene polymorphism increase 
susceptibility to oral cancer. Oral Oncol 47:577-82, 2011 
 
29. 
Bektas-Kayhan K, Unur M, Boy-Metin Z, et al: MCP-1 and CCR2 gene variants in 
oral squamous cell carcinoma. Oral Dis 18:55-9, 2012 
 
30. 
Fujita S, Ikeda T: The CCL2-CCR2 Axis in Lymph Node Metastasis From Oral 
Squamous Cell Carcinoma: An Immunohistochemical Study. J Oral Maxillofac Surg 75:742-749, 
2017 
 
31. 
Yang J, Lv X, Chen J, et al: CCL2-CCR2 axis promotes metastasis of 
nasopharyngeal carcinoma by activating ERK1/2-MMP2/9 pathway. Oncotarget 7:15632-47, 
2016 
 
32. 
Muller A, Sonkoly E, Eulert C, et al: Chemokine receptors in head and neck cancer: 
association with metastatic spread and regulation during chemotherapy. Int J Cancer 118:2147-57, 
2006 
 
33. 
Gillison ML, Chaturvedi AK, Anderson WF, et al: Epidemiology of Human 
Papillomavirus-Positive Head and Neck Squamous Cell Carcinoma. J Clin Oncol 33:3235-42, 
2015 
 
34. 
Castellsague X, Alemany L, Quer M, et al: HPV Involvement in Head and Neck 
Cancers: Comprehensive Assessment of Biomarkers in 3680 Patients. J Natl Cancer Inst 
108:djv403, 2016 
 
35. 
Auvynet C, Baudesson de Chanville C, Hermand P, et al: ECL1i, d(LGTFLKC), a 
novel, small peptide that specifically inhibits CCL2-dependent migration. FASEB J 30:2370-81, 
2016 
 
36. 
Williams JW, Elvington A, Ivanov S, et al: Thermoneutrality but Not UCP1 
Deficiency Suppresses Monocyte Mobilization Into Blood. Circ Res 121:662-676, 2017 
 
37. 
Liu Y, Li W, Luehmann HP, et al: Noninvasive Imaging of CCR2(+) Cells in 
Ischemia-Reperfusion Injury After Lung Transplantation. Am J Transplant 16:3016-3023, 2016 
 
38. 
Liu Y, Gunsten SP, Sultan DH, et al: PET-based Imaging of Chemokine Receptor 
2 in Experimental and Disease-related Lung Inflammation. Radiology 283:758-768, 2017 
 
 
 


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25 
APPENDIX A: Definitions for Adverse Event Reporting 
 
A. 
Adverse Events (AEs) 
 
As defined in 21 CFR 312.32: 
 
Definition: any untoward medical occurrence associated with the use of a drug in humans, whether 
or not considered drug-related. 
 
Grading: the descriptions and grading scales found in the revised NCI Common Terminology 
Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.  A copy 
of the CTCAE version 5.0 can be downloaded from the CTEP website. 
 
Attribution (relatedness), Expectedness, and Seriousness: the definitions for the terms listed that 
should be used are those provided by the Department of Health and Human Services’ Office for 
Human Research Protections (OHRP).  A copy of this guidance can be found on OHRP’s website: 
http://www.hhs.gov/ohrp/policy/advevntguid.html 
 
B. 
Suspected Adverse Reaction (SAR) 
 
As defined in 21 CFR 312.32: 
 
Definition: any adverse event for which there is a reasonable possibility that the drug caused the 
adverse event.  “Reasonable possibility” means there is evidence to suggest a causal relationship 
between the drug and the adverse event.  “Suspected adverse reaction” implies a lesser degree of 
certainty about causality than adverse reaction, which means any adverse event caused by a drug. 
 
C. 
Life-Threatening Adverse Event / Life Threatening Suspected Adverse Reaction  
 
As defined in 21 CFR 312.32: 
 
Definition: any adverse drug event or suspected adverse reaction is considered “life-threatening” 
if, in the view of the investigator, its occurrence places the patient at immediate risk of death. It 
does not include an adverse event or suspected adverse reaction that, had it occurred in a more 
severe form, might have caused death. 
 
D. 
 Serious Adverse Event (SAE) or Serious Suspected Adverse Reaction 
 
As defined in 21 CFR 312.32: 
 
Definition:  an adverse event or suspected adverse reaction is considered “serious” if, in the view 
of the investigator, it results in any of the following outcomes: 
o Death 
o A life-threatening adverse event 


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26 
o Inpatient hospitalization or prolongation of existing hospitalization 
o A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
o A congenital anomaly/birth defect 
o Any other important medical event that does not fit the criteria above but, based upon 
appropriate medical judgment, may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed above 
 
E. 
Protocol Exceptions 
Definition: A planned change in the conduct of the research for one participant. 
Unforeseen Imaging Exception:  Research imaging protocols which involve the injection 
of radioactive tracers can produce unique situations not common to standard treatment 
protocols.  In the event a situation occurs which requires deviation from this protocol – for 
example less than expected tracer production, problems with the scanner, patient unable to 
tolerate the imaging protocol as described, the Principal Investigator will have final 
authority over whether or not a study is completed.  Any protocol deviations will be 
documented on the PET imaging data form.  Deviation such as less than expected tracer 
production can be accounted for during data analysis and will not necessarily result in 
cancellation of the scan.  Similarly, adjusting imaging procedures to accommodate patient 
comfort can also be accounted for at the time images are reviewed.   
 
Except as described above, pre-approval of all protocol exceptions must be obtained prior to 
the event 
 
F. 
Deviation 
Definition: Any alteration or modification to the IRB-approved research without prospective IRB 
approval.  The term “research” encompasses all IRB-approved materials and documents including 
the detailed protocol, IRB application, consent form, recruitment materials, questionnaires/data 
collection forms, and any other information relating to the research study. 
 
A minor or administrative deviation is one that does not have the potential to negatively impact 
the rights, safety, or welfare of participants or others or the scientific validity of the study. 
 
A major deviation is one that does have the potential to negatively impact the rights, safety, or 
welfare of participants or others or the scientific validity of the study. 
 
 


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3 
APPENDIX B: Reporting Timelines 
 
Expedited Reporting Deadlines  
Event 
HRPO 
QASMC 
FDA 
Serious AND 
unexpected 
suspected adverse 
reaction 
 
 
Report no later than 15 
calendar days after it is 
determined that the 
information qualifies for 
reporting 
Unexpected fatal or 
life-threatening 
suspected adverse 
reaction 
 
 
Report no later than 7 
calendar days after initial 
receipt of the information 
Unanticipated 
problem involving 
risk to participants 
or others 
Report within 10 working 
days.  If the event results in 
the death of a participant 
enrolled at WU/BJH/SLCH, 
report within 1 working day. 
Report via email 
after IRB 
acknowledgment 
 
Major deviation 
Report within 10 working 
days.  If the event results in 
the death of a participant 
enrolled at WU/BJH/SLCH, 
report within 1 working day. 
 
 
A series of minor 
deviations that are 
being reported as a 
continuing 
noncompliance 
Report within 10 working 
days.   
 
 
Protocol exception 
Approval must be obtained 
prior to implementing the 
change 
 
 
Clinically important 
increase in the rate 
of a serious 
suspected adverse 
reaction of that list 
in the protocol or IB 
 
 
Report no later than 15 
calendar days after it is 
determined that the 
information qualifies for 
reporting 
 
Complaints 
If the complaint reveals an 
unanticipated problem 
involving risks to 
participants or others OR 
noncompliance, report 
within 10 working days.  If 
the event results in the death 
of a participant enrolled at 
WU/BJH/SLCH, report 
within 1 working day.  
Otherwise, report at the time 
of continuing review. 
 
 


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4 
Expedited Reporting Deadlines  
Event 
HRPO 
QASMC 
FDA 
Breach of 
confidentiality 
Within 10 working days. 
 
 
Incarceration 
If withdrawing the 
participant poses a safety 
issue, report within 10 
working days.   
 
If withdrawing the 
participant does not 
represent a safety issue and 
the patient will be 
withdrawn, report at 
continuing review. 
 
 
 
 
 


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5 
 
 
Routine Reporting Requirements 
Event 
HRPO 
QASMC 
FDA 
Adverse event or 
SAE that does not 
require expedited 
reporting 
If they do not meet the 
definition of an unanticipated 
problem involving risks to 
participants or others, report 
summary information at the 
time of continuing review 
Adverse events will 
be reported in the 
toxicity table in the 
DSM report which 
is typically due 
every 6 months. 
The most current toxicity 
table from the DSM 
report is provided to the 
FDA with the IND’s 
annual report. 
Minor deviation 
Report summary information 
at the time of continuing 
review. 
 
 
Complaints 
If the complaint reveals an 
unanticipated problem 
involving risks to 
participants or others OR 
noncompliance, report within 
10 working days.  If the 
event results in the death of a 
participant enrolled at 
WU/BJH/SLCH, report 
within 1 working day.  
Otherwise, report at the time 
of continuing review. 
 
 
Incarceration 
If withdrawing the 
participant poses a safety 
issue, report within 10 
working days.   
 
If withdrawing the 
participant does not represent 
a safety issue and the patient 
will be withdrawn, report at 
continuing review. 
 
 
 

ICF_001.pdf: 
 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
INFORMED CONSENT DOCUMENT 
 
Project Title: 
Imaging CCR2 Receptors with 64Cu-DOTA-ECL1i in Head and Neck Cancer 
 
Principal Investigator: 
Farrokh Dehdashti 
 
Research Team Contact: 
Jennifer Frye (314-747-1604)  
 
This consent form describes the research study and helps you decide if you want to participate.  It 
provides important information about what you will be asked to do during the study, about the risks and 
benefits of the study, and about your rights and responsibilities as a research participant. By signing this 
form you are agreeing to participate in this study. 
• You should read and understand the information in this document including the procedures, 
risks and potential benefits.  
• If you have questions about anything in this form, you should ask the research team for more 
information before you agree to participate.   
• You may also wish to talk to your family or friends about your participation in this study. 
• Do not agree to participate in this study unless the research team has answered your 
questions and you decide that you want to be part of this study.  
 
KEY INFORMATION: 
This is a research study conducted by Dr. Farrokh Dehdashti having to do with newly diagnosed head 
and neck cancer. You should carefully consider the information in this consent document and discuss it 
with the research team. Be sure you understand why you might want to participate, or why you might 
not want to participate. You may choose to participate or not. 
 
If you agree and sign this consent, you will be volunteering to participate in the research study. All of 
the information below will be explained and is listed in more detail in the consent document below. The 
research team must give you a copy of this signed consent document. 
 
How will this study affect me? 
 
• The purpose of this study is to see if a specialized scan can be used in the future to give doctors 
more information and help determine the best possible treatment for a person with a new 
diagnosis of head and neck cancer.    
• As a voluntary participant, you will be asked to spend approximately 3 hours at the hospital for 
the scan. 
• You were selected because you are scheduled to receive surgery or other treatment for your 
newly diagnosed head and neck cancer. 
• Your active time in this study will be for about 3 hours on a day before your scheduled surgery 
or start of treatment. 
o You will be in the study until your surgery has been completed or you have started non-
surgical treatment.   


 
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APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
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Page 2 of 13 
• You will need to come to Barnes-Jewish Hospital Main Campus located in central St. Louis near 
Kingshighway Blvd. and Highway 40/64.   
• The main risks to you are a small amount of radiation exposure from the injection of the study 
medication and discomfort from lying on the scanning table.  More detail about risks is provided 
on pages 5 and 6 of this document. 
• You will be paid up to $250 for participating in this study. You will not have costs for 
participating.  
• If you withdraw from the study, the research team may continue to use information already 
collected about you in this study.  
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study.  We invite you to participate in this research study because you have been 
diagnosed with head and neck cancer and will be scheduled for surgery or other treatment.   
 
The purpose of this research study is to see if a Positron Emission Tomography (PET) imaging agent 
called 64Cu-DOTA-ECL1i can provide more information about your cancer. The primary goal is to see if 
64Cu-DOTA-ECL1i PET imaging can predict how well you will respond to surgery or other treatment.  
 
64Cu-DOTA-ECL1i is considered investigational, which means that it has not been approved by the U.S. 
Food and Drug Administration.   
 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
To participate in this study, you will be asked to read and sign this consent form before any study 
procedures are performed. Your study doctor and staff will determine if you are eligible to continue to 
participate by reviewing your medical history, medical records, current medications, and imaging scans. 
Standard medical procedures that are part of your regular cancer care and probably would be done even 
if you do not join the study will be reviewed along with those procedures that are done for research 
purposes only.  
 
Imaging Day: After obtaining informed consent study procedures will begin.  If you are woman capable 
of becoming pregnant, a blood or urine pregnancy test will be performed to confirm you are not 
currently pregnant and can continue on study.  Two IVs will be placed in a vein of your arm or hand.  If 
possible we will try to place one IV in each arm.  One IV will be used to give you the 64Cu-DOTA-
ECL1i PET imaging agent.  The second IV, whenever possible,will be used to draw blood samples at 
several different time points during the imaging day.   
• Your current height and weight will be recorded. 
• A sample of blood (approximately 3 teaspoons) of blood will be taken from your IV line for 
standard laboratory testing (complete blood count and organ function).   Additional blood 
samples described below will be taken and used to measure how quickly 64Cu-DOTA-ECL1i is 
taken up by your  organs from the blood stream (serum stability) and how quickly it is processed 
and leaves your body (metabolites).     
• Your blood pressure, heart rate, breathing rate, and temperature (Vital signs) will be recorded. 


 
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APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
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Page 3 of 13 
• An electrocardiogram (ECG or tracing of your heart) will be recorded.  For this test, stickers will 
be placed on your chest, shoulders, arms and legs.  A series of wires will be hooked up to the 
stickers allowing a machine to recording a tracing of your heart.  
 
You will be asked to empty your bladder in the restroom before the start of the scan.  Throughout the 
scanning day you will be asked to drink water or other fluids and use the restroom as frequently as 
possible.  You might also receive saline or water through your IV line to help you use the restroom more 
often. 
 
Scan #1 All Patients:  At all scanning time points you will be made as comfortable as possible 
while laying on your back on the imaging table.  Warm blankets will be provided along with 
cushions to place under your knees.  You will be asked to lie with your arms resting either down to 
your sides or above your head depending on the type of scan being done and what is most 
comfortable for you. The scanner will be a combination PET/CT scanner and is used to take pictures 
of your body.  PET scanners allow us to image the function of different cells and organs in the body.  
The CT scan (computed tomography) is a type of x-ray scan that images the anatomy (size or 
structure) of the body in two dimensions.  The combined PET/CT scanner is a special type of 
scanner that allows us to image both structure (CT) and function (PET) following the injection of 
64Cu-DOTA-ECL1i.     
 
For the first scan you will be asked to lie on the imaging table.  Following a low dose CT scan of 
your head and neck you will be positioned in the scanner so that your known site of disease is at the 
center of the scan.  The 64Cu-DOTA-ECL1i imaging tracer will be given to you through one of your 
IV lines.  The PET scan will start at the same time you are given the imaging tracer.   
 
• You will rest comfortably inside the scanner for approximately 65-70 minutes while the 
scan is acquired.   
• Approximately 5 minutes after the start of the scan a small sample of blood (approximately 
½ a teaspoon) will be drawn from your IV line for serum stability and metabolite 
measurements.  At the end of the scan a second (approximately ½ teaspoon) sample of 
blood will be drawn for the same purpose. (whenever possible)   
• At the end of the scan you will be removed from the scanner and given a short break.  
During this time, your vital signs will be recorded.   
• You will be asked to empty your bladder in the restroom.   
 
Scan #2 All Patients:  After a short break you will be asked to lie on the scanning table again.  A 
low dose CT scan of your upper body (from head to upper / mid chest) will be obtained.  The total 
amount of time needed for this scan will be about 15 minutes.     
 
Discharge Imaging Day before you leave the PET facility at the end of the imaging day the 
following tests / procedures will be performed: 
• Your vital signs and ECG will be recorded. 
• A small sample of blood (approximately 3 teaspoons) will be collected for standard 
laboratory testing (complete blood count and organ function).  
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 4 of 13 
Scanning Follow up:  at least 24 hours after your scanning day you will be contacted by telephone.  
You will be asked how you have been feeling since your scanning day in an attempt to see if you 
have had any complications or problems that might be associated with the injection of 64Cu-DOTA-
ECL1i or the PET/CT scans.  If you are going to surgery soon after the scan has finished this follow 
up might not occur until after your surgery day.   
 
Study Discharge:  You will be considered off study after you have had surgery as planned.  If, for 
some reason you do not receive surgery the study will follow your medical record until you have 
started on a recommended treatment.   
 
Tissue Testing:  different types of cancers are known to express different types of proteins.  The role of 
these proteins in cancer is still being studied.   One protein that is being studied in a number of different 
types of cancer is CCR2 (C-C motif chemokine receptor 2).  Overexpression of CCR2 may be 
associated with more aggressive forms of cancer.  If tissue is available (from your original biopsy, or at 
the time of surgery) we will request a small sample of tissue for CCR2 testing.  The results of the CCR2 
testing of your tissue will be compared to your 64Cu-DOTA-ECL1i scans to see if the scans give 
additional information about CCR2 levels.   
 
Study Results:  the results of your standard laboratory testing will be reported and included in your 
medical record.  The results of your 64Cu-DOTA-ECL1i scans, CCR2 tissue testing, your ECG tracings 
and vital sign measurements are done only for study purposes and will not be made available to you or 
your doctors through your medical chart.  If any of these tests provide additional information which is 
significant enough to change or influence your medical care (for example a scan that shows different or 
additional treatment might be needed or surgery may not be the best possible treatment for you at this 
time) this information will be communicated to your treatment team by phone call or secure email.  If 
this would happen the doctor / team who is treating you will discuss the findings with you.  The imaging 
team is always available to answer your questions as well.   
 
Will you save my research information and/or biospecimens to use in future research studies?  
  
We would like to use the data and tissue we are obtaining in this study for studies going on right now as 
well as studies that are conducted in the future.  These studies may provide additional information that 
will be helpful in understanding CCR2’s role in cancer, or other diseases or conditions, including 
research to develop investigational tests, treatments, drugs or devices that are not yet approved by the 
U.S. Food and Drug Administration.  It is unlikely that what we learn from these studies will have a 
direct benefit to you.  There are no plans to provide financial compensation to you should this occur.  By 
allowing us to use your data and tissue you give up any property rights you may have in the data and 
tissue.   
 
Your data and tissue will be stored without your name or any other kind of link that would enable us to 
identify which sample(s) or data are yours.  Therefore, it will be available for use in future research 
studies indefinitely and cannot be removed. 
 
Identifiers may be removed from your private information including data and tissue and used for future 
research or shared with others. If this occurs, we will not ask you for additional consent.  


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
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Page 5 of 13 
HOW MANY PEOPLE WILL PARTICIPATE? 
 
Approximately 20 people will take part in this study conducted by investigators at Washington 
University.   
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your active participation will last for approximately 3 hours on a 
day before you are scheduled to undergo surgery or start treatment.  You will be contacted by phone at 
least 24 hours after your scan do for a quick (5 min) follow up assessment.    
 
WHAT ARE THE RISKS OF THIS STUDY? 
 
You may experience one or more of the risks indicated below from being in this study. In addition to 
these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this 
study.  
 
Some risks described in this consent document, if severe, may cause death.  
 
IV Placement and Blood Drawing: 
• Mild / Likely: discomfort from placement of the IV in your arm or hand or from the needle used 
to draw blood 
• Serious /Less Likely: There is a slight risk of bruising, some people feel dizzy or faint when an 
IV is placed or blood is drawn from them 
• Life Threatening / Rare: There is a rare risk of infection at the site of IV placement or blood 
drawing. 
 
ECG: You may feel discomfort from the placement and removal of the electrode patches from the skin.  
Remaining still while the ECG is taken (less than 1 minute) may cause anxiety. 
 
Vital Signs: You may feel discomfort from the squeezing of the blood pressure cuff around your arm. 
 
64Cu-DOTA-ECL1i Injection:   
Mild / Likely:    pain or discomfort at the injection site.  Temporary altered taste sensation.  You 
may notice a metallic or other unusual taste at the back of your throat following injection.  If 
this occurs it usually is gone within a short period of time after the injection.     
Life Threatening / Rare:  While none have been reported to date, there is a possibility of an allergic 
reaction to 64Cu-DOTA-ECL1i.  Signs or symptoms of allergic reaction include a rash, fast 
pulse rate, sweating, a feeling of dread, swelling of the face, mouth, throat or extremities, 
wheezing or difficulty breathing, or a sudden drop in blood pressure making you feel dizzy or 
lightheaded. 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 6 of 13 
 PET/CT Scan: 
Mild / Likely: discomfort from lying on the imaging table including but not limited to backache, 
shoulder and arm discomfort and general feeling of stiffness following the scan. 
 
Life Threatening / Rare: Malfunction of worn or implanted electronic medical devices If you have 
electronic medical devices implanted such as a pacemaker or a drug pump, please make sure you 
tell your study doctors and research staff.  The CT scan may cause a malfunction of electronic 
medical devices. 
 
Radiation Exposure: This study will expose you to radiation from the injection of the radioactive drug 
64Cu-DOTA-ECL1i and from CT scanning used as part of the PET/CT scan.  The amount of radiation 
from this, when averaged over your entire body, is approximately 18% of the amount a person who 
works with radiation is allowed to have in one year.   
 
The risk from the radiation exposure in this study is too small to be measured.  It is not a big risk when 
compared with other risks you take every day.  If you want to know more about radiation exposure, 
please see the “Radiation Fact Sheet” at http://hrpo.wustl.edu or ask the study staff for a copy. 
 
Failed Tracer Production or Scanner Problems 
There is a possibility that the 64Cu-DOTA-ECL1i imaging tracer which is made especially for you will 
not be available on the planned day of scanning due to failed production or the scanner needed to 
perform your scan may not be working properly. These failures are possible and may not be known until 
you have arrived for your study procedure. This situation may be an inconvenience to your time. 
Depending on where you are with your treatment plan, another date for 64Cu-DOTA-ECL1i production 
and PET/CT scan may be scheduled if you are agreeable. 
 
Women Capable of Becoming Pregnant 
If you are a woman capable of becoming pregnant, we will ask you to have a pregnancy test before 
beginning this study.  You must use effective birth control methods and try not to become pregnant 
while participating in this study.  If you become pregnant, there may be unknown risks to your unborn 
child, or risks to your unborn child that we did not anticipate.  There may be long-term effects of the 
treatment being studied that could increase the risk of harm to an unborn child.  You must tell the doctor 
if your birth control method fails while you are on the study. If you believe or know you have become 
pregnant while participating in this research study, please contact the research team member identified at 
the top of this document as soon as possible.  Please discuss with the research team how long you need 
to wait before becoming pregnant after completing the treatment or procedures on this study. 
 
Radiation Exposure in Women Capable of Becoming Pregnant 
You may not participate in this study if you are pregnant.  If you are capable of becoming pregnant, we 
will perform a pregnancy test before exposing you to research-related radiation.  You must tell us if you 
may have become pregnant within the previous 14 days because the pregnancy test is unreliable during 
that time. 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
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Sexually Active Male 
If you are a sexually active male it is important that your partner not become pregnant during your 
participation in this study.  There may be unknown risks to the unborn child or risks we did not 
anticipate.  You and your partner must agree to use birth control if you want to take part in this study.  If 
you believe or know that your partner has become pregnant during your participation in this study, 
please contact the research team member identified at the top of this document as soon as possible. 
 
Breach of Confidentiality 
One risk of participating in this study is that confidential information about you may be accidentally 
disclosed.  We will use our best efforts to keep the information about you secure.  Please see the section 
in this consent form titled “How will you keep my information confidential?” for more information. 
 
 WHAT ARE THE BENEFITS OF THIS STUDY? 
 
You will not benefit from being in this study. 
 
However, we hope that, in the future, other people might benefit from this study because scans such as 
64Cu-DOTA-ECL1i PET/CT imaging may help personalize treatments based on the function of an 
individual’s particular cancer.     
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
You will not have any costs for being in this research study.  
 
You and/or your medical/hospital insurance provider will remain responsible for your regular medical 
care expenses. 
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will be paid for being in this research study. You will need to provide your social security number 
(SSN) in order for us to pay you. You may choose to participate without being paid if you do not wish to 
provide your social security number (SSN) for this purpose.  You will also need to provide your address 
so a check can be mailed to you. It can take 4-6 weeks for the check request to be processed and have 
your check mailed to the address you provide.  If your social security number is obtained for payment 
purposes only, it will not be retained for research purposes.    
 
We recognize and appreciate the time and effort to participate in a research study.  In addition to parking 
fees, you will receive compensation to cover additional costs you may encounter, such as meals, extra 
time at hospital away from work or family, and/or other unforeseen expenses related to your 
participation and completion of the imaging visits of study.  The amount you will be paid is broken 
down into $100 for each imaging time point and $50 for the blood draws for a total of up to $250.  
Overnight hotel stay(s) may be available if needed. If you arrive for your scheduled scan and the tracer 
production fails, you will receive $25 for you time and trouble.  If you do not complete all parts of the 
study, you will be paid for those parts you do complete.  
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 8 of 13 
WHO IS FUNDING THIS STUDY? 
 
The National Institutes of Health is funding this research study.  This means that Washington University 
is receiving payments from the National Institutes of Health to support the activities that are required to 
conduct the study.  No one on the research team will receive a direct payment or increase in salary from 
the National Institutes of Health for conducting this study. 
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
Washington University investigators and staff will try to reduce, control, and treat any complications 
from this research. If you feel you are injured because of the study, please contact the investigator at 
314-362-1474 and/or the Human Research Protection Office at 1-(800)-438-0445.  
 
Decisions about whether payment for medical treatment for injuries relating to your participation in 
research will be made by Washington University.  If you need to seek medical care for a research-related 
injury, please notify the investigator as soon as possible.  
 
HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL? 
 
Other people such as those indicated below may become aware of your participation in this study and 
may inspect and copy records pertaining to this research.  Some of these records could contain 
information that personally identifies you. We will keep your participation in this research study 
confidential to the extent permitted by law.   
• Government representatives (including the Office for Human Research Protections) to complete 
federal or state responsibilities 
• The U.S. Food and Drug Administration 
• The National Institutes of Health 
• Your primary care or treatment physician if a medical condition that needs urgent attention is 
discovered 
• Hospital or University representatives to complete Hospital or University responsibilities 
• Information about your participation in this study may be documented in your health care records 
and will be available to anyone with access to your health care record, including your health 
insurance company.  This information may also be released as part of a release of information 
request. 
• The last four digits of your social security number may be used in hospital or University systems 
to track billing information for research procedures. 
• Washington University’s Institutional Review Board (a committee that oversees the conduct of 
research involving human participants) and the Human Research Protection Office. The 
Institutional Review Board has reviewed and approved this study.  
• Any report or article that we write will not include information that can directly identify you.  
The journals that publish these reports or articles require that we share your information that was 
collected for this study with others to make sure the results of this study are correct and help 
develop new ideas for research. Your information will be shared in a way that cannot directly 
identify you. 
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 9 of 13 
To help protect your confidentiality, we will store all paper documents behind two locks.  All electronic 
data will be password protected and stored on a password protected computer.  The tissue that is being 
tested will be de-identified to a study specific ID.  It will only be available to study team members and 
will be stored behind two locked doors at all times.  The results from tissue testing will be recorded on 
either a paper document or electronically and will be protected as indicated above.   
 
The Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital 
is supported by funding from the National Cancer Institute (NCI). To meet NCI requirements, your 
protected health information relating to your participation in this study (including your social security 
number) will be stored in a secure database at the Siteman Cancer Center.  This database and also your 
health care records may be reviewed by Siteman Cancer Center personnel.  All information will be 
securely and confidentially maintained.  
 
To further protect your privacy, this research is covered by a Certificate of Confidentiality from the 
federal government. This means that the researchers can refuse to disclose information that may identify 
you in any legal or court proceeding or to anyone who is not connected with the research except if:  
• there is a law that requires disclosure, such as to report child abuse and neglect, or harm to self or 
others;  
• you give permission to disclose your information, including as described in this consent form; or 
• it is used for other scientific research allowed by federal law. 
You have the right to share your information or involvement in this study with anyone at any time. You 
may also give the research team permission to disclose your information to a third party or any other 
person not connected with the research.  
 
If information about you or your involvement in this research is placed in your medical record the 
information may no longer be protected under the Certificate. However, information in your medical 
records is protected in other ways.    
 
A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.  
 
Are there additional protections for my health information? 
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal 
law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this 
research, you must give the research team permission to use and disclose (share) your PHI for the study 
as explained in this consent form.  The research team will follow state and federal laws and may share 
your health information with the agencies and people listed under the previous section titled, “How will 
you keep my information confidential?” 
 
Once your health information is shared with someone outside of the research team, it may no longer be 
protected by HIPAA.   
 
The research team will only use and share your information as talked about in this form or as permitted 
or required by law.  When possible, the research team will make sure information cannot be linked to 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 10 of 13 
you (de-identified).  Once information is de-identified, it may be used and shared for other purposes not 
discussed in this consent form. If you have questions or concerns about your privacy and the use of your 
PHI, please contact the University’s Privacy Officer at 866-747-4975.  
 
Although you will not be allowed to see the study information, you may be given access to your health 
care records by contacting your health care provider.  
 
If you decide not to sign this form, it will not affect: 
• your treatment or the care given by your health provider. 
• your insurance payment or enrollment in any health plans.   
• any benefits to which you are entitled. 
However, it will not be possible for you to take part in the study. 
 
If you sign this form: 
• You authorize the use of your PHI for this research. 
• This authorization does not expire. 
• You may later change your mind and not let the research team use or share your information 
(you may revoke your authorization).  
• To revoke your authorization, complete the withdrawal letter, found in the Participant section 
of the Human Research Protection Office website at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the 
investigator send you a copy of the letter.    
 
 
 
o If you revoke your authorization: 
 The research team may only use and share information already collected for 
the study. 
 Your information may still be used and shared as necessary to maintain the 
integrity of the research, for example, to account for a participant’s 
withdrawal from the research study or for safety reasons. 
 You will not be allowed to continue to participate in the study. 
 
Can we contact you by email? 
 
We would like to contact you by email for the purposes listed below.  Some of these emails may contain 
health information that identifies you. 
• Confirming appointment dates and times and to provide maps or parking instructions to our 
imaging facility. 
   
Only the research team will have access to your email communications.  We will only communicate by 
email to send you the information listed above.  If you have any questions or need to contact us for an 
urgent or emergent situation, please contact the research team member identified at the top of this 
document. 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 11 of 13 
You should be aware that there are risks associated with sending your health information via email.   
• There is always a risk that the message could be intercepted or sent to the wrong email 
address.  To avoid sending messages to the wrong email address, the first email we send you 
will be a test message to ensure we have the correct email address. 
• When using any computer you should be careful to protect your username and password.  
Make sure you log-out before getting up from the computer.   
• If you share a home computer with other family members, and do not want them to know you 
are participating in this study make sure you provide an email address that only you can 
access.  
• Your employer will have access to any email communications sent or received on any 
electronic devices used for work or through a work server. 
  
Do you agree to allow us to send your health information via email?   
 
_____ Yes  
_____ No 
Initials 
Initials 
 
IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If 
you decide to be in this study, you may stop participating at any time. Any data that was collected as 
part of your participation in the study will remain as part of the study records and cannot be removed.   
 
If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or 
lose any benefits for which you otherwise qualify.   
 
What if I decide to withdraw from the study? 
 
You may withdraw by telling the study team you are no longer interested in participating in the study or 
you may send in a withdrawal letter. A sample withdrawal letter can be found at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research 
Study. 
 
Will I receive new information about the study while participating? 
 
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information. 
 
Can someone else end my participation in this study? 
 
Under certain circumstances, the investigator might decide to end your participation in this research 
study earlier than planned.  This might happen for no reason or because staying in the study may be 
harmful, you need treatment that is not allowed while on the study, you fail to follow instructions, you 
develop a major side effect, the scanner or imaging tracer is not available and rescheduling would delay 
your treatment or the study is cancelled. 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
Page 12 of 13 
 
WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact Dr. Farrokh Dehdashti at 314-362-1474.   If you experience a research-related injury, please 
contact: Dr. Farrokh Dehdashti at 314-362-1474.  
 
If you have questions, concerns, or complaints about your rights as a research participant, please contact 
the Human Research Protection Office 1-(800)-438-0445, or email hrpo@wustl.edu.   General 
information about being a research participant can be found on the Human Research Protection Office 
web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to 
speak to someone other than the research staff, call the Human Research Protection Office at the number 
above. 
 
 
This consent form is not a contract. It is a written explanation of what will happen during the study if 
you decide to participate. You are not waiving any legal rights by agreeing to participate in this study. 
As a participant you have rights and responsibilities as described in this document and including: 
• To be given enough time before signing below to weigh the risks and potential benefits and 
decide if you want to participate without any pressure from the research team or others. 
• To understand all of the information included in the document, have your questions answered, 
and receive an explanation of anything you do not understand. 
• To follow the procedures described in this document and the instructions of the research team to 
the best of your ability unless you choose to stop your participation in the research study. 
• To give the research team accurate and complete information. 
• To tell the research team promptly about any problems you have related to your participation, or 
if you are unable to continue and wish to stop participating in the research study. 
 
Your signature indicates that this research study has been explained to you, that your questions have 
been answered, and that you agree to take part in this study.  You will receive a signed and dated copy 
of this form. 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 09/17/24. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Participant) 
 
 
 
 
(Date) 
 
 
____________________________________________ 
(Participant's name – printed) 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201912003 
APPROVAL DATE: 09/19/23 
RELEASED DATE: 09/20/23 
EXPIRATION DATE: 09/17/24 
 
Ver #5 08/28/2023 
 
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Statement of Person Who Obtained Consent 
 
The information in this document has been discussed with the participant or, where appropriate, with the 
participant’s legally authorized representative.  The participant has indicated that they understand the 
risks, benefits, and procedures involved with participation in this research study. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date) 
 
 
___________________________________________ 
(Name of Person who Obtained Consent - printed)