Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Sponsor: University of Wisconsin, Madison

 
 
 
Use of ICG-fluorescence imaging for sentinel lymph 
node mapping in patients with breast cancer 
 
IRB Approval Date: 2/23/23 
 
 
NCT05859971 

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PROTOCOL TITLE: 
 
Use of ICG-fluorescence imaging for sentinel lymph node mapping in patients 
with breast cancer 
LEAD RESEARCHER: 
Heather B. Neuman, MD, MS 
Department of Surgery 
608-262-2025 
neuman@surgery.wisc.edu 
 
VERSION NUMBER/DATE: 
Version 1. November 29, 2022 
 
REVISION HISTORY 
 
Revisio
n # 
Version Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NOTE: Leave this section blank for the initial submission. The revision history should be 
documented for modifications to approved studies.  
 

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Table of Contents 
1.0 
Study Summary .................................................................................................... 3 
2.0 
Background .......................................................................................................... 4 
3.0 
Study Objectives and Endpoints ........................................................................... 5 
4.0 
Number of Participants ......................................................................................... 5 
5.0 
Inclusion and Exclusion Criteria ............................................................................ 5 
6.0 
Special Populations .............................................................................................. 6 
7.0 
Recruitment Methods ............................................................................................ 6 
8.0 
Consent/Assent Process ...................................................................................... 6 
9.0 
Process to Document Consent in Writing ............... Error! Bookmark not defined. 
10.0 Setting .................................................................................................................. 6 
11.0 Study Intervention ................................................................................................. 7 
12.0 Study Timelines .................................................................................................... 7 
13.0 Procedures Involved ............................................................................................. 7 
14.0 Comparison of usual care and study procedures ................................................ 10 
15.0 Withdrawal of Participants .................................................................................. 10 
16.0 Data Management and Confidentiality ................................................................ 10 
17.0 Provisions to Protect the Privacy Interests of Participants ................................... 12 
18.0 Sharing of Results .............................................................................................. 12 
19.0 Data and Specimen Banking .............................................................................. 12 
20.0 Study Analysis .................................................................................................... 12 
21.0 Potential Benefits to Participants ........................................................................ 13 
22.0 Risks to Participants ........................................................................................... 13 
23.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 14 
24.0 Economic Burden to Participants ........................................................................ 15 
25.0 Resources Available 15 
26.0 Multi-Site Research ............................................................................................ 15 
27.0 References ......................................................................................................... 15 
28.0 Appendices ............................................................ Error! Bookmark not defined. 
 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Use of ICG-fluorescence imaging for sentinel lymph node 
mapping in patients with breast cancer 
Brief Summary 
The primary objective is to determine the feasibility of using 
ICG fluorescence through the Asimov Imaging Platform for 
sentinel lymph node mapping by comparing lymphatic 
visualization using blue dye and technetium sulfur colloid 
(standard of care) versus ICG fluorescence imaging. We will 
enroll 10 patients and assess the image acquisition 
parameters of using ICG fluorescence through the Asimov 
Imaging Platform for sentinel lymph node mapping 
 
Number of study 
sites 
One 
Study Design 
Prospective, single arm feasibility study 
Primary Objective 
To determine the feasibility of using ICG fluorescence 
through the Asimov Imaging Platform for sentinel lymph 
node mapping by comparing lymphatic visualization using 
blue dye and technetium sulfur colloid (standard of care) 
versus ICG fluorescence imaging. 
Secondary 
Objective(s) 
To assess the image acquisition parameters of using ICG 
fluorescence through the Asimov Imaging Platform for 
sentinel lymph node mapping 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
ICG-fluorescence Imaging 
Drugs/devices used 
on study (including 
any IND/IDE #)  
Onlume Asimov Imaging Platform 
Study Population 
Breast cancer patients with clinical T1 or T2, node negative 
breast cancer undergoing sentinel lymph node mapping 
Sample Size 
10 
Study Duration for 
individual 
participants 
21 days (day of procedure and post-operative visit) 
Study Specific 
Abbreviations/ 
Definitions  
NA 
Note: Include only elements relevant to this study. 
 

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2.0 
Background 
2.1 Sentinel lymph node (SLN) mapping is the current standard of care to stage 
the axillary lymph nodes for women with clinically node negative axilla.1-3 
Mapping is most commonly performed with radioisotope technetium-99 
sulfur colloid and/or vital blue dye. Using this approach, mapping rates 
exceed 95% with a low false negative rates (5-10%).3-5 
Although the current approach is effective, there are some gaps.  
Technetium-99 sulfur colloid is often injected in nuclear medicine prior to 
the operating room (either same day or day prior).6 This adds complexity to 
scheduling of operating room cases as well as cost. In addition, technetium-
99 sulfur colloid is an ionizing agent which means that this approach cannot 
be used in hospital settings without a nuclear medicine department. It also 
requires extensive safety protocols to be in place. Finally, national 
shortages in technetium-99 sulfur colloid have been experienced during 
and since the pandemic which highlight the need for an alternative mapping 
agent.  
In addition, there are some limitations to the use of technetium-99 sulfur 
colloid for SLN mapping from a patient perspective. The same scheduling 
issues regarding injection can be inconvenient for patients, especially those 
that live further from the hospital.  Similarly, these injections can be very 
painful, given they occur at the edge of the areola.7,8 Patients often ask why 
these injections can’t happen intra-operatively after they have received 
anesthesia; this is not feasible for many nuclear medicine departments 
workflow.  
 
2.2 Indocyanine green (ICG) has been described as a dye for SLN mapping 
since the early 2000’s.9 A recent clinical trial comparing SLN identification 
rates for 100 patients receiving technetium colloid, blue dye, and ICG 
demonstrated non-inferiority between ICG and technetium colloid, with 
successful mapping of 96.1%.10  
ICG is increasingly used in breast cancer surgery for a variety of 
indications, including lymphatic mapping for lymphedema treatment and 
assessment of tissue viability during reconstruction.11-18 Consequently, 
many centers have already overcome one of the most significant barriers to 
the use of ICG mapping, specifically that it requires an intra-operative 
imaging device. Given the potential to cut costs and improve patient 
experiences by avoiding the pre-operative injection, there is value in 
considering the use of ICG for SLN mapping.  
Several potential challenges to using ICG for SLN mapping exist. 
First, challenges exist related to the devices used to detect ICG 
fluorescence. Many devices designed for ICG cannot optimally be used 
with ambient light, making it challenging to use to actively guide surgical 
dissection into the OR. In this proposal, we will determine the feasibility of 
using the Asimov Imaging Platform for fluorescence-guided surgery in the 
operating room. The Asimov can be used without altering external (i.e., 
room) light functionality or levels. In addition, it is mounted on an arm that 
can be positioned over the operative field. This facilitates real-time 

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visualization of lymphatics to support sentinel lymph node mapping during 
the dissection and would represent a significant advancement.  
 
 
 
The second challenge relates to the penetration of the ICG imaging through 
skin and soft tissue.  With the technetium, the option exists to obtain an 
image in radiology confirming the mapping was successful before coming to 
the OR; this allows for the potential for a second injection if needed for slow 
mapping. In the OR, a handheld probe is then used to localize the location 
of the lymph nodes in order to plan placement of the axillary incision. 
However, ICG fluorescence does not have the same depth of tissue 
penetration as technetium. In a recent clinical trial, the lymph nodes were 
not able to be visualized prior to skin incision using a hand-held 
fluorescence imaging device called Fluobeam 800. Consequently, the 
investigators planned their skin incision to be just lateral to the pectoralis 
muscle (where the majority of breast lymph nodes are located). Importantly, 
the ICG fluorescence was successful in identifying the sentinel lymph 
nodes once the skin incision was made. Given variation in device design, it 
is important to assess the feasibility of the Asimov Imaging Platform in 
identifying sentinel lymph nodes prior to and after skin incision. 
 
The objective of this study is to assess the feasibility of using fluorescence-guided 
surgery with ICG dye through the Asimov Imaging Platform for the sentinel lymph node 
mapping. We will continue to use blue dye and technetium sulfur colloid to guide clinical 
decision making (standard of care).6  We will then compare the ICG fluorescence 
findings using the Asimov imaging Platform (research) with the blue dye and technetium 
sulfur colloid (standard of care).   
 
3.0 
Study Objectives and Endpoints 
 
Specific Aim 1: To determine the feasibility of using ICG fluorescence through the 
Asimov Imaging Platform for sentinel lymph node mapping by comparing lymphatic 
visualization using blue dye and technetium sulfur colloid (standard of care) versus ICG 
fluorescence imaging.  
 
Specific Aim 2: To define optimal image acquisition parameters of using ICG 
fluorescence through the Asimov Imaging Platform for sentinel lymph node mapping to 
inform the clinical workflow. 
2a. To define dynamic range of ICG fluorescence signal in lymph nodes and 
background tissue. 
2b. To assess image contrast as a function of ICG dose and time post-injection. 
 
 
4.0 
Number of Participants 
We plan to enroll 10 patients in this feasibility pilot study. 
 
5.0 
Inclusion and Exclusion Criteria 
 

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5.1. Screening and recruitment: Patients being cared for by Dr. Neuman within 
the UW Breast Center will be eligible for consideration.  Dr. Neuman will 
identify eligible patients from her clinical practice.  
 
5.2 Inclusion criteria:  
• ≥ 18 years of age 
• Diagnosis of clinical T1 or T2 breast cancer clinically node negative breast 
cancer requiring surgical lymph node evaluation  
• Surgery at University of Wisconsin Hospital and Clinic 
5.3 Exclusion criteria: 
• Pregnant: It is not known whether indocyanine green can cause fetal harm 
when administered to a pregnant woman or can affect reproduction 
capacity. Women of child-bearing age will undergo a urine pregnancy test 
on the day of surgery, which is standard of care prior to anesthesia. 
• Breastfeeding: It is not known whether this drug is excreted in human milk. 
Because many drugs are excreted in human milk, caution should be 
exercised when indocyanine green is administered to a nursing woman. 
We will exclude women who are breastfeeding. 
• Unable to provide informed consent 
• Allergy to indocyanine green 
• History of ipsilateral breast or axillary surgery 
6.0 
Special Populations 
We will not enroll special populations in this feasibility pilot study. 
 
 
7.0 
Recruitment Methods 
7.1 Dr. Neuman will identify eligible patients from her clinical practice.  
7.2 Dr. Neuman will introduce the study to them at the time of their clinic 
visit. A member of the study team will then discuss the study in 
detail with interested patients. As much time as needed will be given 
for potential subjects to decide whether or not to participate in this 
study. Subjects will be informed that they are not obligated to 
participate in the study.  
 
8.0 
Consent/Assent Process 
 
The consent process will occur either at the Breast Center or in the pre-operative area 
on the day of surgery, based on whether a member of the study team is available to 
approach the patient on the day of their clinic visit. Patients will then be consented in a 
closed private room. Subjects will receive a copy of the consent form and will be given 
contact information for member of the study team and PI for any additional questions.  
 
9.0 
Setting 
 

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Patients will be recruited from the UW Breast Center.  Surgery will occur within 
the operating rooms at UW Health. 
 
10.0 Study Intervention 
 
Standard of Care Procedures: 
SLN mapping using technetium-99m +/- isosulfan blue dye: For patients enrolled in the 
study, sentinel lymph node mapping and biopsy will be performed using technetium-99m 
sulfur colloid and isosulfan blue dye (unless there is a contraindication to blue dye); this 
is an acceptable standard of care.6 Injection of the technetium-99m sulfur colloid will be 
performed by the nuclear medicine team as per standard of care.  The isosulfan blue 
dye injection will be performed by the participating surgeon in the operating room; as per 
standard of care, injection will be subareolar. Incisions will be planned based on the 
technetium-99m activity or at the lateral aspect of the pectoralis muscle, per usual care. 
 
Research Procedures: 
SLN mapping with ICG fluorescence using the Asimov Platform: The research 
procedures will include using ICG-fluorescent imaging for the SLN mapping. OnLume 
will provide a sterile drape designed specifically for the OnLume Asimov Platform.  25 
mg of ICG and 10 mg Sterile Water will be dispensed for injection by UW Health 
pharmacy. Before the image acquisition of each patient, ICG will be reconstituted under 
sterile conditions with Sterile Water (2.5 mg/1 ml). The vial will be gently shaken to 
dissolve. Reconstituted ICG must be used within 6 hours after reconstitution. The total 
dose of dye will be kept below 2 mg/kg of patient body weight. The dose of ICG to be 
injected is based on the existing literature.9,10 2 ml (5 mg) of ICG solution will be injected 
intradermally in 1-4 injection sites in the lateral areolar region.10 After injection, gentle 
manual massage will be performed for 5 minutes. ICG imaging will be obtained prior to 
incision. After incision is made (following standard of care procedures), the axilla will be 
visualized using the Asimov Platform to assess for ICG-fluorescence in sentinel lymph 
nodes. 
 
Impact on clinical care of the ICG mapping: The objective of this study is to evaluate the 
feasibility of using ICG fluorescent imaging through the Asimov Imaging Platform for 
SLN mapping. Compared to other platforms, the Asimov Imaging Platform allows real 
time imaging without altering ambient light. Clinical decisions regarding which lymph 
nodes are considered sentinel lymph nodes (and should be removed) will be made 
based technetium-99 activity and/or vital blue dye, as per standard of care. However, we 
will image with the Asimov Platform throughout to determine whether ICG-fluorescent 
imaging would have led to identification of different lymph nodes.  
 
11.0 Study Timelines 
The duration of an individual participant’s participation is limited to the OR day 
and the post-operative visit. We anticipate enrolling the 10 participants in <12 
months.  
 
12.0 Procedures Involved 
 
Patients will be consented either in clinic or on the day of surgery.  A medical record 
review will collect pre-operative and post-operative data.  We will inject the ICG and 

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collect imaging data as described above. We will collect procedural data related to the 
ICG injection and fluorescent imaging. We will assess adverse events related to the 
injection at the post-operative visit.  
 
Overview of Study Calendar 
Visit Number  
Screening/recruitment Pre-op 
Medical 
Record 
Review 
Day of 
Surgery 
Post-op 
Visit 
Post-op 
Medical 
Record 
Review  
Informed Consent/Assent  
X  
 
  
 
 
Review Eligibility  
X  
 
  
 
 
Demographics/prior 
medical history/clinical 
tumor characteristics 
X 
  
 
 
Pregnancy Test  
  
 
X  
 
 
Operative data collection  
  
 
X  
  
  
Fluorescent Imaging Data 
 
 
X 
 
 
Pathologic tumor 
characteristics 
 
 
  
  
X  
Adverse Event 
Assessment  
  
 
X  
X  
  
 
 
Medical Record Review: We will collect data through UW Health electronic medical 
record review. We will record limited demographics about the patient including: age, 
race/ethnicity, BMI, type of breast surgery, receipt of neoadjuvant systemic therapy, prior 
receipt of radiation, clinical and pathologic cancer stage (tumor size and lymph node 
status), and receptor status (estrogen receptor, progesterone receptor, her2neu).  We 
will also collect surgical and pathologic details related to breast/axillary surgery. 
 
 
Operative data collection: 
We will collect the following procedural data:  
• 
We will document whether ICG-fluorescence is visualized prior to 
incision (yes/no). 
• 
At each time point when the axilla is examined for technetium-99 
activity, we will document whether technetium-99 activity, ICG-
fluorescence and blue dye is visualized We will also document 
whether lymphatic vasculature is visualized with the ICG-
fluorescence or blue dye. 
• 
Each lymph node removed will be assessed for blue dye, 
technetium-99 activity, and ICG fluorescence and the findings 
recorded.  
• 
Time ICG is mixed, injection, time of start and end of massage, 
start of axillary surgery, time of removal of lymph nodes, time of 
fluorescent imaging 

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• 
Number of lymph nodes removed.  For removed lymph nodes, we will 
record whether removed lymph nodes had radiotracer, blue dye, or 
fluorescence.  
• 
After removal of sentinel lymph nodes, we will document whether 
there is residual background technetium-99 activity and ICG-
fluorescence in the axilla.  
 
Imaging data: 
Subjects will receive fluorescence imaging using the Asimov Imaging Platform. 
Beginning at the time of ICG injection, image and video capture of contemporaneous 
white light reflectance and fluorescence imaging will be collected. Following the 
operation, post-processing will be conducted to elucidate injection technique superiority. 
We will use quantitative fluorescence to define optimal image acquisition parameters. In 
order to evaluate injection technique performance, the critical image acquisition 
parameters that provide surgeons detectable contrast (CNR) and fluorescence 
intensities in the lymphatic vessels and SLN will be measured with respect to post-
injection time at each time point the axilla is examined.  
 
Adverse Event Assessment:  We will assess for complications related to the 
injection of the ICG intraoperative and at the post-operative visit.  
 
Regulatory status of drugs and devices:  
The Onlume Asimov Imaging Platform is a non-significant risk device. A letter supporting 
this is attached.  
 
ICG is FDA approved as an optimal imaging agent for visualization of lymph nodes and 
lymphatic vessels. The Investigational Drug Brochure is attached to this application.  
ICG contrast meets requirements for IND exemption because: 
(i) 
ICG is lawfully marketed in the United States 
(ii) 
The investigation focuses on the Asimov Imaging Platform is not intended to 
be reported to FDA in support of a new indication for use nor intended to 
support any other significant change in the labeling for ICG;  
(iii) 
This investigation focusing on the Asimov Imaging Platform is not intended to 
support a significant change in the advertising for ICG;  
(iv) 
The investigation does not involve a route of administration or dosage level 
or use in a patient population or other factor that significantly increases the 
risks (or decreases the acceptability of the risks) associated with the use 
ICG. ICG has been used extensively in clinical practice with an exceedingly 
good safety profile. 
(v) 
The investigation is conducted in compliance with the marketing limitations 
described in 21 CFR § 312.7. 
. 
 
 

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13.0 Comparison of usual care and study procedures 
If patients chose to not participate in this study, they will receive usual standard of care 
treatment for their cancer. This would include SLN mapping as per standard of 
care using technetium-99 +/- vital blue dye.  
 
 
14.0 Withdrawal of Participants 
Patients will be withdrawn from the study at their request. In addition, if their 
clinical situation evolves so that the SLN mapping is longer applicable to them or 
they no longer meet eligibility criteria, they will be withdrawn. 
 
15.0 Data Management and Confidentiality 
15.1  Describe the steps the researchers will take to secure the data (e.g., 
training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and 
data) during storage, use, and transmission. If HIPAA rules apply to the 
study, review information on the Office of Compliance HIPAA page and 
consult HIPAA Privacy and Security Coordinators to ensure that data 
management methods are compliant. Select all that apply: 
☐ Data will be coded, and the “key” linking identities to codes will be 
kept separately from the data. 
☐ Data will be coded, and the “key” linking identities to codes will be 
kept on paper only. The study data will be stored electronically 
and labeled only with codes. 
☐ Only those listed as key personnel will have access to the “key.” 
☐ Access to the “key” will be limited to the following person (e.g., 
Database Administrator): ________________________________ 
☐ This study is funded by the National Institutes of Health 
and is covered by a Certificate of Confidentiality. 
☐ This study is NOT funded by the National Institutes of 
Health but because it will collect sensitive information, the 
research team will apply for a Certificate of Confidentiality 
to protect data from being requested without the subject’s 
consent as part of a legal proceeding. 
☐ Other: _______________________________________________ 
 
 
15.3 Describe how and where data and/or specimens will be stored and 
maintained. Select all that apply: 
∎ Online Collaborative Research Environment (OnCore) 
Biospecimen Management 
∎ Research Electronic Data Capture (REDCap) Specify 
which instance you will be using (e.g., ICTR’s, Department 
of Medicine’s): _________________________________ 

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☐ Other software option that will be stored on departmental 
server. Specify the department: 
______________________ 
☐ Locked filing cabinet or drawer inside a locked room. 
Specify the building: _Clinical Science Center 
(K6)______________________ 
☐ Other (describe): _______________________________ 
☐ Data will not be stored or accessed on portable devices. 
☐ Portable devices will be used to access secure web-based 
data collection sites such as ICTR’s REDCap. No data will 
be stored locally on the device. 
☐ Data stored on portable devices will be coded with the key 
stored separately. No identifiers will be stored on portable 
devices. 
☐ Data stored on portable devices and therefore only 
encrypted devices will be used. 
 
15.4 Management of Identifiers:  
☐ Identifiers will be destroyed after all data has been 
collected. 
☐ Identifiers will be destroyed at study closure. 
☐ Identifiers will be destroyed at study closure or at the time 
of publication. 
 
15.5 Describe any planned sharing of data and/or specimens outside the 
study team / institution. Include sharing required by funding 
agencies and publications. 
 
Imaging data will be coded with a unique sample ID # (e.g., 123) and will be stored on 
the secure surgery server and on the OnLume’s off-campus data server. Data will be 
transferred using an encrypted USB drive. No PHI will be stored on the OnLume data 
server. The subject code is linked to a separate spreadsheet, which lists the subject 
number and the patient identifiable information including medical record number. The 
code will be stored separately from the research data on the secure Department of 
Surgery server. All electronic data is password and firewall security protected. When a 
patient is imaged through the Asimov Imaging Platform, only the subject ID will be 
entered into the system. In this way, the imaging will always be “coded” from the time of 
image acquisition. From the OnLume system, the imaging data will be transferred using 
an encyrpted USB hard drive. Once data is confirmed to be successfully transferred to 
OnLume and the secure Dept. of Surgery server, it will be permanently deleted from the 
imaging platform. 
 
Datasets containing patient identifiers will not be copied or shared with others outside of 
the UW study team for analysis. Only datasets without identifiers can be shared for 
analysis; the Onlume team will only receive coded data. Upon completion of this 
research, the link to identifiable information will be destroyed, permanently de‐identifying 
the data. 
 
 

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16.0 Provisions to Protect the Privacy Interests of Participants 
16.1 Describe the steps that will be taken to protect participants’ privacy 
interests. “Privacy interest” refers to a person’s desire to place limits 
on with whom they interact or to whom they provide personal 
information. If any of the following apply, check the box for 
convenience: 
☐ Procedures will be performed in a private area where 
others cannot see the procedures being performed or 
overhear the conversation between subjects and 
researchers. 
☐ All members of the study team are up to date on their institutional 
HIPAA training. 
☐ The study is not collecting information that could pose legal 
or reputational risks to participants. 
 
The consent process will occur at the Breast Center and pre-operative 
areas of UW Health. Subjects will be consented in a closed private room 
by a member of the study team. As much time as needed will be given for 
potential subjects to decide whether or not to participate in this study. 
 
Patients being cared for by Dr. Neuman within the UW Breast Center will 
be eligible for consideration. Dr. Neuman will identify eligible patients from 
her clinical practice and introduce the study to them. A study team 
member will then discuss the study in detail and obtain informed consent. 
Once consent is obtained, a member of the research team with valid, 
approved access to HealthLink will conduct the chart abstraction from the 
health care record. 
 
17.0 Sharing of Results  
 
This is a feasibility study where patients’ care will proceed using standard of care 
means.  Dr. Neuman will share with an individual patient the ICG-fluorescent imaging 
findings post-operatively at patients’ request. Results will not be reported in the health 
record.  
 
18.0 Data and Specimen Banking 
We are not planning to retain data collected for future unrelated research 
projects.  
 
19.0 Study Analysis 
Baseline demographic and outcome variables will be summarized using 
descriptive statistics. We will report whether ICG-fluorescent lymph nodes were 
visualized percutaneously (prior to incision). We will describe concordance rates 
between technetium-99 and ICG-fluorescence for each sentinel lymph node 
removed (mean 2.8 nodes with a standard deviation of 2.2).4 We will also assess 
concordance at the patient level; using the technetium-99 as the gold standard, 

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we will describe the number of lymph nodes that would have been missed (i.e. 
technetium-99 + but ICG- in removed SLN) or would have been excised 
unnecessarily (i.e. residual ICG-fluorescence in axilla but no residual technetium-
99) if ICG-fluorescent imaging had guided the SLN. We will summarize any 
adverse events. 
 
Planned reporting of concordance rates between technetium-99 and ICG 
per excised sentinel lymph node 
 
Technetium-99 + 
Technetium-99 - 
Total 
ICG + 
 
 
 
ICG - 
 
 
 
Total 
 
 
 
 
 
20.2 Sample Size Justification:  
 
No power calculation is calculated for this feasibility study.  We anticipate that the 
sample size of 10 will be enough to assess initial feasibility of this approach 
and whether further study is warranted.  
 
20.0 Potential Benefits to Participants 
 
There is no direct benefit to patient participation in this study. 
 
 
21.0 Risks to Participants 
 
There are low risks expected related to study participation. 
 
Potential risks from ICG are minimal as it is a well-known, FDA-approved dye 
that has a very good safety profile (adverse event rate: 1 in 42,000) when 
administered intravenously.11,19,20 Adverse events can range from a redness of 
the skin or hives, up to cough or difficulty swallowing.  In the operating room, 
these would be treated with medication such as antihistamines, H2 blockers, 
and/or epinephrine. Although ICG is approved for intravenous administration, it 
has been safely injected into interstitial, subcutaneous (SC) or intradermal 
locations in hundreds of patients, including breast tissue. In a recent trial of 100 
patients undergoing SLN with ICG-fluorescence, no ICG-related complications or 
adverse events were reported. In our own experience at UW using ICG for a 
lymphatic mapping study, no ICG-related complications have been experienced 
for the 6 patients enrolled to date. Similarly, no adverse reactions have been 
reported in other studies evaluating ICG for lymphatic mapping, with study sizes 
as large as 689 patients.14-17,21 
 
Potential risks from the use of the OnLume Asimov Imaging platform are low 
since the imaging device will be used in a similar manner as its FDA 510(k) 
clearance. The duration of the surgery is not expected to be significantly longer in 

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duration (<20 minutes) with the additional use of the OnLume System imaging 
than with just the standard of care. Per discussions with anesthesia staff, the 
additional time for anesthesia poses no foreseeable additional risk to the patient. 
The risk associated with the injection of the dye will be minimized by close 
observation of the patient after injection. Injection will occur in the OR when 
extensive monitoring is already occurring. 
 
As with any study, there is a remote risk of breach of confidentiality. This risk has 
been minimized through data protection efforts. Only approved study personnel 
will have access to the direct identifiers. 
 
 
22.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
 
The PI and study team will be involved in ongoing monitoring for data and safety concerns.   
 
Our proposed phase II, non-blinded clinical trial represents a low risk of adverse events, 
and the described DSMP is commensurate with this level of risk. The PI and study team 
will meet weekly to discuss recruitment, accrual and retention of participants. They will 
also review any safety concerns during these meetings. The study team will discuss data 
quality monthly.  The study team has developed a comprehensive checklist of study 
activities that resides within a regulatory binder.  This will be reviewed before and after 
each patient is enrolled.  
 
We feel that the risks to participating in this study are minimal and our research team will 
be continually reviewing data and subject safety at weekly study team meetings to 
discuss study progress including recruitment/enrollment, data integrity, and adverse 
events (AEs). This study will utilize the Common Terminology Criteria for Adverse 
Events (CTCAE) version 5.0 for routine toxicity and adverse event (AE) reporting. 
Incisional pain, breast seromas, and breast/arm swelling are expected events after 
breast and axillary surgery. We will consider injection site reactions, such as redness of 
the skin or hives, to be unexpected adverse events. We also consider allergic reactions 
to the dye (such as cough or difficulty swallowing) to be unexpected adverse events. We 
will submit any unanticipated adverse effects to sponsor and to the IRB as soon as 
possible, but no event later than 10 working days after the investigator first learns of the 
effect. Unexpected and immediately life-threatening or severely debilitating events, 
whether related to the ICG or the Asimov Imaging Platform, will be reported with 1 
business day. 
 
The focus of this study is to test the feasibility of ICG mapping through the Asimov 
Imaging Platform. Potential advantages to the Asimov Imaging Platform compared to 
other means of immunofluorescence detection is that it allows real time imaging without 
altering ambient light.  
 
Only coded data related to the imaging acquisition will be stored on the OnLume off 
campus data server. Data will be transferred on an encrypted USB drive to OnLume. 
After confirmation that the data has transferred and is not been corrupted, the source 
data will be deleted from the imaging platform.  Imaging data will also be stored on the 
surgery servers using the same method of encrypted USB. No PHI will be stored outside 
of the UW Department of Surgery secure server (see section that follows). 

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23.0 Economic Burden to Participants 
 
There are no direct costs to patients to participating in this study.  
 
24.0 Resources Available 
 
Will the research be conducted outside 
School of Medicine and Public Health 
or UW Hospitals and Clinics (e.g. the 
researcher does not have an SMPH 
research feasibility attestation for this 
study)?    
☐ YES (complete 25.1) 
☐ NO (remove text below, but retain this 
section) 
 
 
25.0 Multi-Site Research 
 
NA 
 
26.0 References 
 
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biopsy in breast cancer patients. 2018; 
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Guidelines-for-Sentinel-Lymph-Node-Biopsy-in-Breast-Cancer-Patients.pdf. 

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7. 
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