High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
Phase: NA
Conditions: Primary Malignant Liver Neoplasm
Sponsor: Stanford University

1 
 
 
High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT 
 
 
Principal Investigator: 
 
Andrei Iagaru, MD 
300 Pasteur Drive,  
Stanford, CA 94305 
Phone: xxx-xxx-xxxx 
Fax:xxx-xxx-xxxx  
Email: aiagaru@stanford.edu 
 
 
Co-investigators: 
 
Dan Sze, MD, PhD 
 
 
Study Coordinator: 
 
Jordan Cisneros, BS 
Phone: xxx-xxx-xxxx 
Fax: xxx-xxx-xxxx 
Email: jdcis@stanford.edu 
 
NCT03109262 
 
SRC Protocol / Version 2 / Version Date: 12/18/2017 
 
IRB protocol #39332 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
SCHEMA ............................................................................................................................................ 4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .......................................................... 5 
1. OBJECTIVES ..................................................................................................................................... 6 
1.1 Primary Objective ..................................................................................................................... 6 
1.2 Secondary Objective ................................................................................................................ 6 
2. BACKGROUND .................................................................................................................................. 6 
2.1 Preliminary information .......................................................................................................... 6 
2.2 Study Agent/Device .................................................................................................................. 7 
2.3 Clinicaltrials.gov ....................................................................................................................... 7 
2.4 Rationale ..................................................................................................................................... 7 
2.5 Study Design .............................................................................................................................. 7 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES ......................................... 7 
3.1 Inclusion Criteria ....................................................................................................................... 7 
3.2 Exclusion Criteria ..................................................................................................................... 8 
3.3 Informed Consent Process .................................................................................................... 8 
3.4 Study Timeline ........................................................................................................................... 8 
3.4.1 Primary Completion: .............................................................................................................................. 8 
4. IMAGING AGENT INFORMATION ................................................................................................. 8 
4.1 Study Agent/Device .................................................................................................................. 8 
4.2 Specify the source of the study agent/device. .................................................................. 8 
4.4 Agent Accountability ............................................................................................................... 8 
5. IMAGING SPECIFICS ....................................................................................................................... 8 
5.1 
Modality or Modalities to be used ........................................................................................... 8 
5.2 
Details of Imaging (i.e. dynamic, static, number of scans, etc.) ........................................ 9 
5.3 
Details of processing/analysis ................................................................................................. 9 
6. STUDY PROCEDURES .................................................................................................................... 9 
6.1 
Criteria for Removal from Study ............................................................................................. 9 
7. STUDY CALENDAR ........................................................................................................................ 10 
8. ADVERSE EVENTS AND REPORTING PROCEDURES ......................................................... 10 
8.1 Potential Adverse Events ..................................................................................................... 10 
8.2 Adverse Event Reporting ..................................................................................................... 11 
9. REGULATORY CONSIDERATIONS ............................................................................................ 11 
9.1 Institutional Review of Protocol.......................................................................................... 11 
9.2 Data Management Plan ......................................................................................................... 11 
9.3 Data and Safety Monitoring ................................................................................................. 11 
10. 
MEASUREMENTS ................................................................................................................. 11 
10.1 Primary outcome measure ................................................................................................. 11 
10.2 Measurement Methods ........................................................................................................ 12 
10.3 Measurement Time Points ................................................................................................. 12 
10.4 Response Review ................................................................................................................. 12 
10.5 Secondary outcome measure ........................................................................................... 12 
10.6 Measurement Methods ........................................................................................................ 12 

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10.7 Measurement Time Points ................................................................................................. 12 
11. 
STATISTICAL CONSIDERATIONS ..................................................................................... 12 
11.5  
Statistical Analysis ...................................................................................................... 13 
Appendix:  Inclusion/Exclusion Criteria Checklist ............................................................... 14 
REFERENCES ................................................................................................................................ 15 
 
 
 

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SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligible participant referred for SIRT  
SIRT 
Digital PET/CT  

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
MAA 
Macro aggregated albumin 
IRB 
Institutional Review Board 
IV 
Intravenous 
IA 
Intra-arterial 
SIRT 
Selective internal radiation therapy 
PET/CT 
Positron emission tomography – computed 
tomography 
ROC 
Receiver-Operative-Characteristic 
SUV 
Standardized Uptake Value 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. OBJECTIVES 
 
1.1 Primary Objective 
 
• 
To evaluate the image quality of 90Y PET/CT post SIRT images as compared to 99mTc MAA 
SPECT/CT. 
 
1.2 Secondary Objective 
 
• 
To determine the superior accuracy in both distribution and dosimetry of 90Y PET/CT 
post SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging 
 
2. BACKGROUND 
 
2.1 Preliminary information 
 
Yttrium-90 (90Y) selective internal radiation therapy (SIRT) is a rapidly emerging radionuclide 
treatment modality for hepatic liver malignancy. The majority of patients with hepatocellular 
carcinoma are being treated with glass microspheres (TheraSphere®; Biocompatibles Inc., 
London, UK), while most patients with liver metastasis are being treated with resin 
microspheres (SIR-Spheres®; Sirtex Medical Limited, Lane Cove, Australia). SIRT leads to 
improvements in progression free and overall survival (1-4). Complications are either caused 
by inadvertent deposition of radioactive microspheres outside the liver, in the lungs (radiation 
pneumonitis) or in the gastrointestinal tract (gastroduodenal ulceration), or by direct injury to 
functional liver parenchyma itself (5-7). Reported hepatic toxicity is mostly limited to symptoms 
related to the so-called post-radioembolization syndrome including mild pain, nausea, 
vomiting and fatigue, but may include a more serious clinical syndrome, called 
radioembolization induced liver disease (REILD), with liver insufficiency characterized by 
elevated liver enzymes and bilirubin, jaundice and ascites. REILD occurs in about 5% of the 
patients. It is difficult to treat and often fatal (8).  
 
Individualized dose planning should aim for maximum treatment effect while keeping toxicity 
acceptably low. The current dose calculation methods however are based on empirical 
evidence with regard to both efficacy and safety, without established dose-response 
relationships (9). Resin microsphere activity doses are calculated by body surface area (BSA) 
and fractional liver involvement, while glass microsphere dose calculation is based on a whole 
liver partition model, derived from the medical internal radiation dosimetry pamphlet No. 17 
(10). Although the latter method is more robust it does not take the radiation absorbed dose 
in the tumors or the normal liver tissue into account.  
 
Despite success, there are currently no reliable methods to demonstrate and quantify 
distribution of the treatment doses to the target lesion(s). 90Y PET/CT represents a 
technological leap from 90Y bremsstrahlung SPECT/CT by coincidence imaging of low 
abundance internal pair production. However, image acquisition times are long and the 
resulting quality is suboptimal when using currently available PET/CT scanners. 
 
More than a decade ago, multimodality imaging was introduced into clinical routine with the 
development of the PET/CT. Since then, PET/CT has been widely accepted in clinical imaging 
and has emerged as one of the main cancer imaging modalities. With the recent development 
of combined PET/MRI systems for clinical use, a promising new PET detector technology 
using silicon photomultiplier tubes has become available. The combination of functional 
information delivered by highly sensitive novel PET detectors with the morphologic imaging of 

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CT offers exciting possibilities for clinical applications as well as basic research. However, the 
differences between standard and digital PET detectors are fundamental. Digital PET/CT is 
expected to show advantages over standard PET/CT by decreasing required dose of PET 
radiopharmaceuticals, higher sensitivity and temporal resolution. However, as of now, only 
assumptions can be made about the future clinical role of digital PET/CT, as data about the 
performance of digital PET/CT in the clinical setting are still limited (11). The first ever GE-
made digital PET/CT scanner worldwide will be installed in the Nuclear Medicine and 
Molecular Imaging Clinic. This novel digital PET/CT may allow for faster and higher quality 
images of the therapy agent distribution when compared to historical published data from 
standard PET/CT. 
 
2.2 Study Agent/Device 
Digital PET/CT Scanner 
 
2.3 Clinicaltrials.gov  
This study will be registered on clinicaltrials.gov 
 
2.4 Rationale 
Selective internal radiation therapy (SIRT) is a form of radiation therapy used in interventional 
radiology to treat cancer. It is used for selected patients with unresectable cancers, those that 
cannot be treated surgically, especially hepatic cell carcinoma or metastasis to the liver. 
Despite success, there are currently no reliable methods to demonstrate and quantify 
distribution of the treatment doses to the target lesion(s). 90Y PET/CT represents a 
technological leap from 90Y bremsstrahlung SPECT/CT by coincidence imaging of low 
abundance internal pair production. However, image acquisition times are long and the 
resulting quality is suboptimal when using currently available PET/CT scanners. However, the 
first ever GE-made digital PET/CT scanner worldwide will be installed in the Nuclear Medicine 
and Molecular Imaging Clinic. This novel digital PET/CT may allow for faster and higher quality 
images of the therapy agent distribution when compared to historical published data from 
standard PET/CT.  
 
2.5 Study Design 
This is a non-randomized prospective trial. Patients who are referred to Nuclear Medicine and 
Interventional Radiology for 99mTc MAA SPECT/CT followed by SIRT will be asked to have 
imaging done using the digital PET/CT scanner following the 90Y SIRT injection. This could be 
done during their mandatory 2-hr rest while lying flat (due to closure device), after their 2-hr 
rest period, or the next day after the participant’s SIRT procedure. We will administer 50mL of 
IsoVue 370 contrast to the participant during the CT scan, if there are no contraindications. 
We will not inject additional radiopharmaceutical; instead, we will use the already administered 
90Y from SIRT. This is possible because the digital PET/CT has very sensitive PET detectors. 
A very small amount of radiation (5 mSv) will be given by the attenuation correction CT scan 
in the second PET/CT. 
 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES 
 
3.1 Inclusion Criteria 
• 
Patient is ≥ 18 years old at the time of the scan  
• 
Patient provides written informed consent 
• 
Patient is referred for 90Y SIRT radioembolization of liver tumor(s)  
• 
Patient is capable of complying with study procedures 

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• 
Patient is able to remain still for duration of imaging procedure (approximately 30 
minutes total for digital PET/CT)  
 
3.2 Exclusion Criteria 
• 
Patient is pregnant or nursing 
 
3.3 Informed Consent Process 
 
All participants will be provided a consent form describing the study with sufficient information 
for participants to make an informed decision regarding their participation. Participants must 
sign the IRB approved informed consent prior to participation in any study specific procedure. 
The participant must receive a copy of the signed and dated consent document. The original 
signed copy of the consent document must be retained in the medical record or research file.  
 
3.4 Study Timeline 
 
3.4.1 Primary Completion: 
The study will reach primary completion 36 months from the time the study opens to 
accrual. We estimate 75 patients will be enrolled. 
 
3.4.2. Study Completion: 
The study will reach study completion 36 months from the time the study opens to 
accrual. 
 
4. IMAGING AGENT INFORMATION 
 
4.1 Study Agent/Device  
 
Digital PET/CT Scanner 
 
4.2 Specify the source of the study agent/device.  
 
GE Healthcare 
 
4.3 Describe how the agent will be requested and provide mailing address and phone 
number. 
 
Digital PET/CT Scanner present on Stanford Campus in the hospital. 
 
4.4 Agent Accountability 
 
N/A 
 
 
5. IMAGING SPECIFICS  
5.1 Modality or Modalities to be used 
 
Digital PET/CT 
 

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5.2 Details of Imaging (i.e. dynamic, static, number of scans, etc.) 
Patients will have 99mTc MAA planar and SPECT/CT imaging as part of the standard SIRT 
planning protocol. These images are acquired after administration of 4 mCi of 99mTc MAA in 
the Interventional Radiology suite. The patient will then be given 90Y Spheres (Glass or Resin), 
and after SIRT procedure, will be arrive to NM for digital PET/CT image acquisition with 
diagnostic contrast enhanced CT of the abdomen. We will be administering 50mL of iodinated 
contrast through IV during the CT scan. Next, PET images will be acquired in 3D mode using 
a single bed located over the liver, with a total acquisition time of approximately 30-minutes. 
The PET emission scan is corrected using the segmented attenuation data from the CT scan. 
The PET images are reconstructed both with a standard iterative algorithm (OSEM, two 
iterative steps, 28 subsets), as well as a regularized reconstruction algorithm provided by GE 
Healthcare. All images are reformatted into axial, coronal, and sagittal views and viewed with 
the software available in the Nuclear Medicine and Molecular Imaging Clinic (MIM Software, 
Cleveland, OH). 
 
5.3 Details of processing/analysis 
The 99mTc MAA planar and SPECT/CT imaging and the PET/CT scans will be interpreted by 
ABNM certified Nuclear Medicine physicians. All investigators have significant clinical 
experience and will be blinded to the participant’s medical history and the results of other 
imaging modalities. A consensus read will be obtained for each scan to assess image quality. 
Each lesion will be tabulated and a comparison of lesion detection and radiation absorbed 
dose by each scanner will be conducted. 
 
Currently, 99mTc MAA planar and SPECT/CT images only simulate 90Y radiopharmaceutical 
biodistribution within the liver and tumor(s). Incorporating SurePlan software (MIM) to analyze 
the PET/CT images will determine final dose-volume histogram (DVH) within the liver and 
tumor (s) post 90Y injection. Additionally, 90Y PET/CT and 99mTc MAA planar and SPECT/CT 
biodistribution images can be compared to evaluate 99mTc MAA simulation accuracy. Results 
of this image comparison could potentially impact clinical decision-making moving forward. 
This information will be reported and shared with the referring physicians involved in the care 
of the patient. 
 
6. STUDY PROCEDURES  
6.1 Criteria for Removal from Study 
The Protocol Director may withdraw subjects from the study for one or more of the following 
reasons: failure to follow the instructions of the Protocol Director and/or study staff; 
determination that continuing the participation could be harmful to the subject; the study is 
cancelled or other administrative reasons. 
 
6.2 Alternatives 
 
The alternative is to not participate in the study.  
 
 
 
 
 
 
 

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7. STUDY CALENDAR 
 
  
 
 
Pre-
Study 
 
Day 
1-2 
 
1 
Months 
 
Informed consent 
 
X 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
Medical history 
 
X 
 
 
 
 
 
99mTc MAA planar and SPECT/CT 
imaging 
   
X 
 
 
 
SIRT followed by digital PET/CT  
  
 
X 
 
 
Data analysis 
  
 
X 
 
8. ADVERSE EVENTS AND REPORTING PROCEDURES 
 
8.1 Potential Adverse Events 
We will not inject additional radiopharmaceutical; instead, we will use the already 
administered 90Y from SIRT. This is possible because the digital PET/CT has very sensitive 
PET detectors. There will be additional radiation from the contrast-enhanced CT used in the 
research scan. This research study involves exposure to radiation from CT scans that is not 
necessary for participant’s medical care and is for research purposes only. The additional 
amount of radiation exposure is up to about 5.0 mSv, which is approximately equal to 10% 
of the limit that radiation workers (for example, a hospital x-ray technician) are allowed to 
receive in one year. This amount of radiation involves minimal risk and is necessary to 
obtain the research information desired. 
There is a small volume (50 ml) of iodinated contrast to be given during the CT scan. This 
will require the introduction of an intravenous (IV) catheter. As with any IV catheter, there is 
some discomfort associated with introduction of the catheter. There can also be some 
redness and swelling associated with the catheter placement, but these will usually subside 
quickly. With the contrast injection, there is a risk of contrast extravasation (leakage) into the 
skin which can cause swelling and mild pain. You will be offered a hot or cold compress to 
help mobilize any extravasated contrast, and if very severe, you would be offered the 
appropriate supportive care, which in rare instances includes transfer to the emergency 
room and surgical consultation. 
 
If there is any reason for you not to have the iodinated contrast, it will be omitted at 
physician discretion. 
 
 
 

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8.2 Adverse Event Reporting 
 
We do not anticipate hazardous situations for the subjects as a result of this protocol. 
However, procedures will be in place for verification of correct radiopharmaceutical dose and 
route of administration (i.e., each dose will be double checked for dosimetry and quality by a 
researcher and technologist). Adverse events will be graded according to CTCAE v4.0.  Both 
Serious and Non-Serious Adverse Events will be clearly noted in source documentation and 
listed on study specific Case Report Forms (CRFs).  The Protocol Director (PD) or designee 
will assess each Adverse Event (AE) to determine whether it is unexpected according to the 
Informed Consent, Protocol Document, or Investigator’s Brochures, and related to the 
investigation. For the purposes of this study, the reporting period ends at scan completion. 
There will be no follow-up procedures for this study. Adverse events will be reported in 
adherence to Stanford University’s internal Adverse Event SOP. 
 
9. REGULATORY CONSIDERATIONS 
 
9.1 Institutional Review of Protocol 
 
 
The protocol, the proposed informed consent and all forms of participant information related 
to the study (e.g. advertisements used to recruit participants) will be reviewed and approved 
by the Stanford IRB. Any changes made to the protocol will be submitted as a modification 
and will be approved by the IRB prior to implementation. The Protocol Director will disseminate 
the protocol amendment information to all participating investigators. 
 
9.2 Data Management Plan 
 
Electronic CRF’s and patient records will both be stored electronically using OnCore.  
 
9.3 Data and Safety Monitoring  
 
During the clinical investigation, the Protocol Director will evaluate the progress of the trial, 
including periodic assessments of data quality and timeliness, participant recruitment, accrual 
and retention, participant risk versus benefit, performance of trial sites, and other factors that 
can affect study outcome.  Monitoring of the trial will occur every 12 weeks and a record of 
monitoring activities will be maintained by the study team. 
 
The Stanford Cancer Institute Data and Safety Monitoring Committee (DSMC) will audit study 
related activities to determine whether the study has been conducted in accordance with the 
protocol, local standard operating procedures, FDA regulations, and Good Clinical Practice 
(GCP).  This may include review of regulatory binders, case report forms, eligibility checklists, 
and source documents.  In addition, the DSMC will regularly review serious adverse events 
and protocol deviations associated with the research to ensure the protection of human 
subjects.  Results of DSMC audits will be communicated to the IRB and the appropriate 
regulatory authorities at the time of continuing review, or in an expedited fashion, as needed. 
 
 
10. MEASUREMENTS 
 
10.1 Primary outcome measure 
 
We will evaluate the image quality of the lesions detected with the digital PET/CT scanner 

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and compare with the image quality of the lesions seen on the standard of care pre-therapy 
99mTc-MAA SPECT/CT.  
 
10.2 Measurement Methods 
 
We will use a 5-point Likert scale to assess image quality. 
 
10.3 Measurement Time Points 
 
Images will be analyzed after completion of scanning and processing. Goal is to complete 
this within one month of acquisition. 
 
10.4 Response Review 
 
The 5-point Likert scale will be determined by Nuclear Medicine physicians blinded to the 
diagnosis and results of the other scan, in a randomized order to avoid bias. Two physicians 
will review all scans independently. Both scans of a given patient will be analyzed by one 
physician, then separately by the second physician. 
 
10.5 Secondary outcome measure 
 
We will assess the radiopharmaceutical distribution and dosimetry accuracy of 90Y PET/CT 
by comparing visual distribution discrepancies (if any) and numerical values calculated by 
SurePlan from both 99mTc MAA SPECT/CT and 90Y PET/CT images.  
 
10.6 Measurement Methods 
 
We will use SurePlan software to edge-contour and calculate tumor radiation absorbed dose 
values in both 99mTc MAA SPECT/CT and 90Y PET/CT images. This software will convert 
counts/pixel on the images to radiation absorbed dose measure in Gray. 
 
 
 
10.7 Measurement Time Points 
 
Images will be analyzed after completion of scanning and processing. Goal is to complete 
this within one month of acquisition. 
 
10.8 Response Review 
 
After radiation absorbed dose is measured in both 99mTc MAA SPECT/CT and 90Y PET/CT 
images, the values will be compared on a lesion-by-lesion basis.  
 
 
11. STATISTICAL CONSIDERATIONS 
 
11.1. 
Statistical Design 
 
Single arm prospective study of paired imaging studies. 
 
11.2. 
Randomization 
 
This study is to compare the images from two different scans: standard SPECT/CT and digital 

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PET/CT and patients are scanned with both scanners. No randomization will be done. 
 
 
11.3. 
Accrual estimates 
 
 
 
We expect accrual of 75 patients. There are approximately 100 patients receiving SIRT each 
year at Stanford University. We plan to enroll 25 participants/year (33%) and this is easily 
achievable given our experience with other protocols.  
 
11.4. 
Criteria for future studies 
 
 
 
At this time, there are no future studies planned beyond the initial 75 participants. 
 
11.5  
Statistical Analysis 
 
Statistical analysis is not required for this study since the comparison is between two 
separate modalities with inherently different properties. 
 
 

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Appendix:  Inclusion/Exclusion Criteria Checklist 
 
 
*All subject files must include supporting documentation to confirm subject eligibility. The method of confirmation can 
include, but is not limited to, laboratory test results, radiology test results, subject self-support, and medical record 
review. 
Statement of Eligibility 
By signing this form of this trial I verify that this subject is ☐ eligible / ☐ ineligible for participation in the study. The 
study is approved by the Stanford Cancer Institute Scientific Review Committee, the Stanford IRB, and has financial and 
contractual agreements as required by Stanford School of Medicine’s Research Management Group. 
 
Treating Physician Signature: 
Date: 
Printed Name: 
 
Secondary Reviewer Signature: 
Date: 
Printed Name: 
 
Study Coordinator Signature: 
Date: 
Printed Name: 
 
 
 
 
 
 
 
 
 
Inclusion Criteria 
(From IRB approved protocol) 
Yes 
No 
Supporting Documentation* 
1. Patient is ≥ 18 years old at the time of the 
scan  
 
 
      
2. Patient provides written informed consent 
 
 
      
3. Patient is referred for 90Y SIRT 
radioembolization of liver tumor(s)  
 
 
      
4. Patient is capable of complying with study 
procedures 
 
 
      
5. Patient is able to remain still for duration of 
imaging procedure (approximately 30 minutes 
total for digital PET/CT) 
 
 
      
Exclusion Criteria 
(From IRB approved protocol) 
 
1. Patient is pregnant or nursing 
 
 
      

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Nguyen NC, Vercher-Conejero JL, Sattar A, et al. Image Quality and Diagnostic 
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