Clinical trial NCT05094102
Conditions: Lymphedema Surgery Breast Cancer
Sponsor: University of Wisconsin, Madison
Start date: 2022-05-05; Completion date: 2023-04-27
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.

Detailed description:
Lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal of only the lymphatics of the breast and protection of the lymphatic channels draining the upper extremity during axillary dissection (AD) or sentinel lymph node (SLN) biopsy, thereby reducing the risk of arm lymphedema.

In this prospective study, breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.

The standard of care (blue dye) will be used for clinical care while the OnLume Imaging System is being used to determine feasibility of the product.

Arms: arm 1: Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.
Interventions: intervention 1: OnLume Imaging System intervention 2: Indocyanine green
Intervention descriptions: intervention 1: for fluorescence-guided surgery with ICG dye intervention 2: Indocyanine green is a cyanine dye used in medical diagnostics

Protocol documents:
Prot_SAP_001.pdf: 
 
 
 
 
Intraoperative evaluation of axillary lymphatics for breast cancer 
patients undergoing axillary surgery 
NCT05094102 
11-3-2022 
 


 
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Intraoperative evaluation of axillary lymphatics for breast cancer patients undergoing 
axillary surgery 
 
Principal Investigator:  
Heather B. Neuman, MD, MS 
University of Wisconsin School of Medicine and Public Health  
Associate Professor, Department of Surgery 
600 Highland Avenue 
K6/142 
Madison, WI 53792-7375 
(608) 262-2025 
neuman@surgery.wisc.edu 
 
 
Protocol Version Date: November 3, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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1. Project Summary  
Lymphedema is an incurable and chronic condition where damage or blockage to the lymphatic system 
leads to swelling, pain, numbness, recurring infections, and fibrosis.1-3 Women diagnosed with breast 
cancer undergoing axillary lymph node surgery may develop lymphedema due to damage or blockage 
of the lymphatic vessels that drain the arm. Rates range from 6-46% depending on the extent of axillary 
surgery.1-3 
Axillary reverse mapping (ARM) is a technique performed by breast surgical oncologists as a way to 
potentially decrease the risk of lymphedema from axillary surgeries.4-14 ARM identifies the lymphatic 
channels draining from the arm during primary breast tumor resection and axillary lymph node surgery, 
thereby differentiating those draining the breast vs those draining the arm. To date, ARM is most 
commonly performed using either a blue dye4-7,10 or immunofluorescence9-15. At the time of axillary 
node surgery, the dye is injected in the subcutaneous fat in the upper arm, resulting in enhanced 
visualization of lymphatics. These lymphatics may then be spared, reducing the risk of lymphedema. 
However, significant limitations to the use of blue dye in lymphatic mapping exist. To visualize blue dye, 
the surgeon must dissect through the soft tissue directly to a blue lymphatic, which can result in 
variable success in identifying the ARM nodes and/or lymphatics, as well as a persistent blue stain at 
the site of injection.9,11,12  
Compared to blue dye, fluorescence-guided surgery (FGS) with indocyanine green (ICG) dye 
represents an opportunity to greatly enhance the potential of the ARM procedure to increase the 
surgeon’s confidence in identifying the lymphatic architecture before focusing on the operative field. 
FGS allows the surgeon to visualize lymphatics without the need to dissect directly to the lymphatic 
channels; rather than directly exposing the lymphatics with surgical dissection, the lymphatics can be 
viewed on the imaging platform. In one prospective study evaluating the ARM procedure, patients 
underwent injection with both isosulfan blue dye and ICG.  This study reported that blue dye and ICG 
identified a similar number of lymph nodes but ICG identified greater number of lymphatics draining the 
arm.10 However, challenges also exist in the use of FGS with ICG for ARM surgery. Commercially 
available imaging platforms to support fluorescence-guided surgery do not work with ambient lighting. 
Ambient room light contamination of near-infrared fluorescence (NIRF) signal emitted from 
fluorescence dye injected into the patient typically requires ambient lights in the operating room to be 
dimmed or turned off to capture the fluorescence images. This limits surgeons’ ability to use FGS in 
real-time. Some FGS imagers attempt to compensate for ambient light through background subtraction, 
which leads to reduced image quality due to dynamic range compression, reduced sensitivity due to 
shorter effective collection times, and added display latency.16   
In this proposal, we will assess the feasibility of using the Asimov Imaging Platform for fluorescence-
guided surgery along with ICG in the operating room for the ARM procedure. FGS with ICG is an 
acceptable approach to performing the ARM procedure nationally and internationally9-15. Theoretical 
benefits to the Asimov Imaging Platform exist, specifically that it can be used without altering external 
(i.e., room) light functionality or levels, which will enable real-time visualization of lymphatics using both 
fluorescence and familiar anatomical reference points to support ARM. 
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 axillary reverse mapping procedure. We will use blue dye 
to guide clinical decision making.  We will compare the ICG fluorescence findings (research) with the 
blue dye (standard of care).  Nationally and internationally, both blue dye and FGS with ICG dye are 
used4-14. In this study, we are specifically evaluating the feasibility of the Asimov Imaging Platform for 
fluorescence-guided surgery with ICG dye.   


 
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2. Background and Significance  
Breast cancer is the most common cancer among women globally, with more than 2 million new cases 
diagnosed annually. In the United States, more than 250,000 women a year are diagnosed with breast 
cancer. Surgery is central to cancer treatment, with more than 90% of these patients undergoing 
surgery for tumor resection, mastectomy, or breast reconstruction.17 Survival of breast cancer patients 
has increased substantially as a result of improved, multidisciplinary treatment approaches which 
means that survivors are also living longer with any morbidity resulting from treatment, including 
lymphedema.  
Lymphedema is an incurable and chronic condition where damage or blockage to the lymphatic system 
leads to swelling, pain, numbness, heaviness, recurring infections, and fibrosis.18 Women undergoing 
axillary lymph node surgery may develop lymphedema due to damage or blockage of the lymphatic 
vessels that drain the arm. In affected breast cancer patients, lymphedema often manifests in the arm 
weeks to years after the removal of the primary tumor or radiation therapy. Rates of lymphedema range 
from 6%-46%, depending on the extent of axillary surgery.1-3 A recent systematic review of 72 clinical 
studies (N=29,612 women) revealed that approximately 1 in 5 women who survive breast cancer will 
develop arm lymphedema.3 Not only does lymphedema reduce quality of life, it has long been a feared 
complication of surgical cancer treatment impacting survivorship: fear stems from a patient’s concerns 
regarding the chronic, progressive nature of the condition and the clinician’s relative inability to predict 
or prevent it from occuring.19 Further, associated per patient costs range from $3000 to $16,000 
annually.18 
Because lymphedema may result from iatrogenic damage to upper limb lymphatics during axillary 
lymph node surgery, identification and preservation of arm lymphatics decreases the likelihood of 
lymphatic disruption during axillary lymph node surgery, leading to a lower incidence of upper limb 
lymphedema.4,5,8 Axillary surgery has historically consisted of an axillary lymph node dissection (ALND) 
where between 15 to 20 lymph nodes were removed from the axilla. Lymphedema rates for an ALND 
range between 20% and 40% in published studies.1-3,19 Because of the associated morbidity rates, this 
procedure is now only performed for patients with confirmed axillary disease. For women with clinically 
negative axillary lymph nodes, axillary staging is performed with a sentinel lymph node (SLN) biopsy. 
The SLN biopsy procedure involves pre-operative mapping of the lymphatics to identify one or two 
lymph nodes where the breast would drain to first if the disease had spread. These lymph nodes are 
then removed through a small incision. Lymphedema rates are lower with this procedure, but still range 
from 5% to 7% in prospective randomized controlled trials.20 
Axillary reverse mapping (ARM) is a technique performed by breast surgical oncologists as a way to 
potentially improve the quality of axillary surgeries.4-14 As shown in Figure 1, ARM is utilized to identify 
the lymphatic channels from the arm and differentiate them from the breast lymphatics during primary 
tumor resection and axillary lymph node surgery. To date, ARM is most commonly performed using a 
blue dye or immunofluorescence, which is injected in the subcutaneous fat in the upper arm, resulting 
in enhanced visualization of lymphatics at the time of axillary node surgery.5 Studies have shown that 
lymphedema rates decrease three-fold when using ARM.4-6,8  
Significant limitations to the use of blue dye in lymphatic mapping exist, including its low optical depth 
penetration, insufficient identification rates of the ARM nodes and/or lymphatics, as well as a persistent 
blue stain at the site of injection. Most importantly, the blue lymphatics can only be identified with direct 
dissection onto the lymphatic, something that is challenging when using a small incision (as for a SLN 
biopsy) or in obese patients (where the blue lymphatics are deeper and surrounded by adipose tissue 
making them more difficult to identify). Finally, the blue lymphatics from the arm may actually drain 
outside the operative field and never be visualized due to its low visual penetration depth; in these 
situations, the breast surgeon is less confident whether the blue lymphatic was inadvertently divided, or 
whether it was tracking along a different route. 


 
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A 
B 
C 
 
Figure 1. Axillary reverse mapping (ARM). 
(A) Sentinel lymph nodes and typical 
lymphatic drainage patterns from the breast 
are identified (green).21 Lymphography with 
(B) blue dye is challenging due to the non-
specific binding to the lymphatics (blue) and 
poor signal retention.8 (C) Lymphatic vessels 
are shown clearly with ICG lymphography 
(white).22 Although ICG easily highlights 
large lymphatic vessels, small and critical 
lymphatic vessels, which can be as small as 
1 mm in diameter, are unable to be seen. 
The clinical need in spatial and sensitivity 
resolution highlights the need for improved 
FGS imaging systems.  
Fluorescence-guided surgery (FGS) with indocyanine green (ICG) represents an opportunity to greatly 
enhance the potential of the ARM procedure to increase the surgeon’s confidence in identifying the 
lymphatic architecture before focusing on the operative field.16 As ICG has shown to offer deeper 
optical penetration than blue dye with ability to detect lymphatic channels located up to 2 cm deep, 
surgeons can follow the route of drainage from the injection site through lymphatic vessels to preserve 
its patency.  
In this proposal, we will use 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. This will enable real-time visualization of lymphatics to support ARM and would represent a 
significance advancement.  
Technical gaps in the literature limit our understanding of ICG fluorescence for ARM that impact 
implementation of this approach within the clinical workflow. Specifically, we need to quantify the critical 
image acquisition parameters that provide 1) surgeons’ detection contrast (CNR) of post-injection time 
and 2) fluorescence signal retention of lymphatic vessels. The post-injection time is valuable for 
elucidating the optimal clinical workflow. Although some studies inject more than two hours before 
surgery, others inject immediately before the axillary surgery.9 In healthy patients, ICG typically reaches 
the nearest draining lymph node within 15 minutes,23 but because lymphatic clearance and backflow 
are dependent on the damage to vasculature, the optimal post-injection imaging time point will vary 
depending on the severity of damage to lymphatic vasculature. Thus, the clinical workflow is difficult to 
establish and optimize. 
The fluorescence signal retention is necessary to enable surgeons to identify and be able to see these 
lymphatic vessels during surgery. Previous studies have not provided these parameters, largely due to 
inherent limitations in quantification capabilities of existing fluorescence imaging technology. 
Furthermore, existing fluorescence imaging technology does not provide fluorescence overlay on the 
white light reflectance image. This visualization is critical to provide surgeons with familiar anatomical 
reference points seen with white light that are further enhanced with fluorescence. This fluorescence 
illuminates the lymphatic flow and its location to support appropriate navigation around critical 
structures to preserve patency when possible. 
3. Study Objective and Specific Aims  
Specific Aim 1: To determine the feasibility of using ICG fluorescence through the Asimov Imaging 
Platform for axillary reverse mapping by comparing lymphatic visualization using blue dye (standard of 
care) versus ICG fluorescence imaging.  


 
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Specific Aim 2: To define optimal image acquisition parameters of using ICG fluorescence through the 
Asimov Imaging Platform for axillary reverse mapping to inform the clinical workflow. 
2a. To define dynamic range of ICG fluorescence signal in lymphatic vessels and background. 
2b. To assess image contrast as a function of ICG dose and time post-injection. 
4. Research Design and Methods 
4.1. Study Overview 
Lymphatic drainage from the upper arm is often different from that of the breast, allowing safe removal 
of only the lymphatics of the breast and protection of the lymphatic channels draining the upper 
extremity during axillary dissection (AD) or sentinel lymph node (SLN) biopsy, thereby reducing the risk 
of arm lymphedema.4-14 In this prospective study, breast cancer patients undergoing SLN biopsy (n=0-
20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping 
(ARM) using isosulfan blue dye. Patients will also receive ICG injection with visualization through the 
Asimov Imaging Platform to allow comparison of blue dye versus ICG lymphatic identification.  
We will also define optimal image acquisition parameters of using ICG fluorescence through the Asimov 
Imaging Platform for ARM. We will use quantitative fluorescence to define optimal image acquisition 
parameters. In order to elucidate injection technique superiority, the critical image acquisition 
parameters that provide surgeons detectable contrast (CNR) of post-injection time, and fluorescence 
signal retention of lymphatic vessels will be measured. The post-injection time is valuable for 
elucidating the optimal clinical workflow. The fluorescence signal retention is necessary to enable 
surgeons to identify and be able to see these lymphatic vessels during surgery.  
4.2. Selection of Participants 
Inclusion criteria:  
• 
≥ 18 years of age 
• 
Diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node 
biopsy or axillary lymph node dissection 
• 
Surgery at University of Wisconsin Hospital and Clinic 
Exclusion criteria: 
• 
Pregnant or breast feeding  
• 
Unable to provide informed consent 
• 
Allergy to indocyanine green 
• 
Patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or 
without axillary lymph node dissection, after neoadjuvant chemotherapy 
4.3 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 and introduce the study to them at the 
time of their clinic visit. A clinical research coordinator will then discuss the study in detail and obtain 
informed consent. Participants will have sufficient time to consider participating in this study.  
4.4. Consent Process 
The consent process will occur at the Breast Center. 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. Subjects will receive a copy of the consent form and 


 
6
will be given contact information for study coordinator and PI for any additional questions. Subjects will 
be informed that they are not obligated to participate in the study.  
 
4.5. Study procedures: 
Standard of Care Procedures: 
Axillary surgery: Axillary lymph node dissection or sentinel lymph node biopsy will be performed as 
indicated by the patient’s clinical history. For patients enrolled in the study, sentinel lymph node 
mapping and biopsy will be performed using technetium-99m sulfur colloid only (no injection of 
isosulfan blue dye in the breast), which is an acceptable standard of care. The participating surgeon will 
otherwise follow their usual practice for performing these routine procedures. 
Axillary reverse mapping: Axillary reverse mapping is an acceptable standard of care and has been 
used internationally (including at the UWHC) to reduce the risk of lymphedema for women undergoing 
axillary surgery.4-14 ARM is also currently being studied in an NCI funded trial to determine the extent to 
which ARM reduces lymphedema risk (NCT039270127). We will use the ARM procedure for both the 
axillary lymph node dissection and the sentinel lymph node biopsy. Although the risk of lymphedema is 
lower after a sentinel lymph node biopsy than with an axillary lymph node dissection, it can still occur 
(estimated 5-7%). 
To perform ARM, 2.5 ccs of 1% isosulfan blue dye (10 g/L concentration) will be injected 
subcutaneously in the volar surface of the ipsilateral upper extremity at the bicipital sulcus after 
induction of anesthesia. Participating surgeons at UW Health have experience performing ARM with 
isosulfan blue dye.  During the axillary surgery, identification of lymphatics will be attempted. If 
lymphatics are visualized in the surgical field, lymphatics draining the arm that do not also have 
crossover breast drainage will be spared or reapproximated. Importantly, the ARM procedure does not 
influence the extent of an axillary surgery, as it does not determine whether or not lymph nodes are 
involved with cancer. Rather, the dye maps the pathway of arm lymphatic flow so that these lymphatics 
can potentially be spared during an axillary surgery.  The breast surgeon will use the blue dye to guide 
clinical decision-making for the ARM procedure.  
 
Research Procedures: 
ARM mapping with ICG fluorescence using the Asimov Platform: The research procedures will include 
using ICG fluorescence for the ARM mapping. OnLume will provide a sterile drape designed specifically 
for the OnLume Asimov.  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 for Injection(2.5 mg/1 ml). Shake the vial gently 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.  
ICG dosing described in the literature has varied significantly (Table 1). A total dose of 1 ml (2.5 mg) of 
ICG will be injected subdermally, in divided doses. 0.5 ml will be injected in the subcutaneous fat in the 
volar surface of the upper arm at the bicipital sulcus and 0.5 ml in the 2nd interdigital space. The two 
injection protocol follows the published experience by Abacci, et al. with the goal to improve ICG’s 
circulation through the lymphatic vessels.24 The upper arm injection will be performed within 1 cm of the 
isosulfan blue dye injection and will occur after induction of anesthesia. At least two minutes of 
massage will be performed to promote upper limb lymph flow. Visualization of the lymphatics using the 
Asimov Platform will be attempted  
 


 
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Table 1.  Summary of Injections Methods for ICG in ARM Procedure 
Author 
Dose of ICG injected 
Injection Location 
Noguchi12 
0.1 ml (0.25 mg) 
Inner wrist 
Noguchi11 
0.1 ml (0.25 mg) 
Inner wrist 
Ikeda25 
0.5-1ml (5 mg) 
Upper inner arm 
Ikdea26 
0.5-1 ml (5 mg) 
Upper inner arm 
Sakurai13 
0.15 ml 
Interdigital area 
Foster10 
0.5-3 mg/ml  
Upper arm 
Ma15 
1 ml (0.5 mg/ml) 
Upper arm 
Yuan14 
1 ml (2.5 mg) 
Upper arm 
Abacci24 
1 ml (2.5 mg/ml) in divided doses 
Upper arm, 2nd interdigital space 
 
Subjects will receive fluorescence imaging using the Asimov Imaging Platform. Beginning at the time of 
ICG injection, image and video capture of white light reflectance and fluorescence will be collected.  
Impact on clinical care of the ICG mapping: The objective of this study is to evaluate the feasibility of 
using ICG fluorescence through the Asimov Imaging Platform. Compared to other platforms, the 
Asimov Imaging Platform allows real time imaging without altering ambient light. The presence of ICG 
fluorescence visualized lymphatics will be documented per the research protocol, but will not be used to 
influence surgical decision making. 
4.5. Data Collection 
Operative data related to ARM: For each case, we will also assess whether blue dye identified 
lymphatics were visualized (yes/no) in the nodal basin and whether the blue lymphatic was spared 
(yes/no). We will also assess whether ICG identified lymphatics were visualized (yes/no) in the nodal 
basin and whether the ICG lymphatics were spared (yes/no). Surgical decision making will be guided 
by the blue dye only and the ICG fluorescence will not be considered. However, we will still document 
whether or not the ICG fluorescent lymphatics were spared. We will assess whether intact lymphatic 
channels were present at the completion of the axillary surgery via both techniques (yes/no/not 
assessable). We will record time at start of case, any fluorescent imaging, and completion of axillary 
surgery (defined as removal of last lymph node).  
Chart review demographics and tumor characteristics: We will record other limited demographics about 
the patient including: Age, race/ethnicity, BMI, type of axillary surgery, type of breast surgery, receipt of 
neoadjuvant systemic therapy, prior axillary surgery, 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 record the number of lymph nodes removed. We will indicate whether 
removed lymph nodes had radiotracer, blue dye, or fluorescence. For patients undergoing SLN biopsy, 
this will allow us to assess whether the SLN is the same as the ARM identified node. We will evaluate 
for any additional axillary surgeries or complications related to axillary surgery (infection, lymphedema) 
until 1 year post-surgery. We will document receipt of post-operative radiation. 
Technical data related to ICG fluorescence imaging: Beginning at the time of ICG injection, image and 
video capture of white light reflectance and fluorescence will be collected. Following the operation, 
post-processing will be conducted to elucidate injection technique superiority. Physicians will confirm 
software-assisted lymphatic labels in the video and measure vessel diameters. 
We will use quantitative fluorescence to define optimal image acquisition parameters. In order to 
elucidate injection technique superiority, the critical image acquisition parameters that provide surgeons 
detectable contrast (CNR) of post-injection time, and fluorescence signal retention of lymphatic vessels 
will be measured.  


 
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4.6. Analysis Plan: 
1. Aim 1: To determine the feasibility of using ICG fluorescence for axillary reverse mapping 
through the Asimov Imaging Platform by comparing lymphatic visualization using blue dye 
(standard of care) versus ICG fluorescence imaging: Given the increased optical penetration 
with the ICG lymphatics, we anticipate greater visualization with the ICG. The proportion of 
cases where blue dye visualized lymphatics can be seen after 5 minutes post-injection will be 
reported along with the corresponding 95% confidence interval, which will be constructed using 
the Wilson score method. The same proportion will be reported for the ICG lymphatics. 
Comparisons between visualization of lymphatics by blue dye versus ICG fluorescence imaging 
will be made using test of two proportions. We will also compare whether lymphatics were able 
to be spared and whether intact lymphatic channels were able to be confirmed via both 
techniques. We will also generate descriptive statistics of patient characteristics associated with 
visualization of lymphatics with each approach to explore clinical scenarios when an approach 
may be less effective. For comparisons, the blue dye is considered the standard of care 
comparison.  
 
2. Aim 2: To define optimal image acquisition parameters of using ICG fluorescence through the 
Asimov Imaging Platform for axillary reverse mapping. 
Aim 2a. To define dynamic range of ICG fluorescence signal in lymphatic vessels and 
background: Imaging acquisition parameters generated from image snapshots and videos 
will be summarized using standard descriptive statistics, including means, standard 
deviations, medians and interquartile ranges to characterize the dynamic range of ICG 
fluorescence signal in lymphatic vessels and the background. Nonlinear regression analyses 
will be conducted to statistically model CNR as a function of ICG dose and time.  
Aim 2b. To assess image contrast as a function of ICG dose and time post injection: Image 
contrast (CNR) will be measured for these lymphatics vessels and a time-curve will be 
developed that demonstrate the change in contrast over time. The magnitude of 
fluorescence signal retention of ICG in the lymphatic vessels, which is a function of both 
pharmacokinetics/pharmacodynamics of ICG and the sensitivity of the imaging platform, will 
be measured. Detectable contrast is defined by the Rose criterion: CNR>3.  
 
4.7. Sample Size: 
We will plan to enroll approximately 0-20 patients undergoing SLN biopsy and 0-15 patients undergoing 
an ALND for a total of about 25 patients. The proposed total sample size is sufficient to generate 
descriptive statistics with an adequate level of precision.16 Specifically, the proportion of cases where 
lymphatics can be seen after 5 minutes post-injection will be estimated with a standard error of less 
than 12% and the corresponding 95% confidence interval will be no wider than 40%. 
No power calculation is calculated for this feasibility study. 
4.8. Risks and Benefits to the Participant 
Potential risks: 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.9,16,27 
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, 


 
9
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. A summary of ICG risks by publication on ARM Procedures are shown below in Table 2, 
indicating the low risk profile:  
Table 2. Summary of ICG risks for ICG in ARM Procedure 
Author 
Patient population 
Number of adverse 
reactions/allergies 
Noguchi12 
Review article 
 
Noguchi11 
131 patients 
None reported 
Ikeda25 
98 patients 
Zero. 
Ikeda26 
60 patients 
None reported 
Sakurai13 
372 patients 
Zero. 
Foster10 
23 patients 
Zero. 
Ma15 
44 patients 
None reported 
Yuan14 
689 patients 
None reported 
 
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 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. 
Patients enrolled in this study who are undergoing the sentinel lymph node biopsy will have lymphatic 
mapping of the breast performed using technetium-99m sulfur colloid only (no injection of isosulfan blue 
dye in the breast). The sentinel lymph node biopsy was initially described with blue dye only, but quickly 
incorporated the technetium-99m sulfur colloid as it increased the ease of use and decreased mapping 
failure rates. In current clinical practice, surgeons may choose to perform lymphatic mapping with blue 
dye only, technetium-99m sulfur colloid only, or both. All methods are considered an acceptable 
standard of care. Use of technetium-99m sulfur colloid only represents a negligible risk to participants. 
Potential benefits: This project has the potential to benefit future breast cancer patients by providing 
imaging that enhances ability to identify small vessels in the body, thereby decreasing the risk of 
accidental damage to the vessels and increasing the possibility of effective repair (i.e., anastomosis). 
Potential benefits to science and society in general include refinement of a surgical technique with the 
potential to reduce the risk of lymphedema for breast cancer patients undergoing axillary surgery. 
7. Data and Safety Monitoring Plan  
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.   
 


 
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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. 
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). 
8. Data and Record Keeping 
The PI will manage and oversee all study activities including the collection and protection of research 
data. All UW-Madison personnel and external collaborators involved in the study will have completed 
University-provided human subjects and HIPAA training. The study staff is trained to protect research 
documents and all precautions will be taken to keep records confidential. Any identifying personal 
information collected during the project will be kept secure by the research team in accordance with 
IRB requirements. Only UW investigators and key personnel will have access to these files with PHI. 
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 encrypted 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 for analysis. Only 
datasets without identifiers can be shared for analysis. Upon completion of this research, the link to 
identifiable information will be destroyed, permanently de‐identifying the data. 
 
References 
1. 
Ahn S, Port ER. Lymphedema Precautions: Time to Abandon Old Practices? J Clin Oncol. 
2016;34(7):655-658. 
2. 
Rockson SG. Lymphedema after Breast Cancer Treatment. N Engl J Med. 2018;379(20):1937-
1944. 


 
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3. 
DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast 
cancer: a systematic review and meta-analysis. Lancet Oncol. 2013;14(6):500-515. 
4. 
Beek MA, Gobardhan PD, Klompenhouwer EG, et al. A patient- and assessor-blinded 
randomized controlled trial of axillary reverse mapping (ARM) in patients with early breast 
cancer. Eur J Surg Oncol. 2020;46(1):59-64. 
5. 
Han C, Yang B, Zuo WS, Zheng G, Yang L, Zheng MZ. The Feasibility and Oncological Safety 
of Axillary Reverse Mapping in Patients with Breast Cancer: A Systematic Review and Meta-
Analysis of Prospective Studies. PLoS One. 2016;11(2):e0150285. 
6. 
Ochoa D, Korourian S, Boneti C, Adkins L, Badgwell B, Klimberg VS. Axillary reverse mapping: 
five-year experience. Surgery. 2014;156(5):1261-1268. 
7. 
Thompson M, Korourian S, Henry-Tillman R, et al. Axillary reverse mapping (ARM): a new 
concept to identify and enhance lymphatic preservation. Ann Surg Oncol. 2007;14(6):1890-
1895. 
8. 
Tummel E, Ochoa D, Korourian S, et al. Does Axillary Reverse Mapping Prevent Lymphedema 
After Lymphadenectomy? Ann Surg. 2017;265(5):987-992. 
9. 
Abbaci M, Conversano A, De Leeuw F, Laplace-Builhe C, Mazouni C. Near-infrared 
fluorescence imaging for the prevention and management of breast cancer-related 
lymphedema: A systematic review. Eur J Surg Oncol. 2019;45(10):1778-1786. 
10. 
Foster D, Choy N, Porter C, Ahmed S, Wapnir I. Axillary reverse mapping with indocyanine 
green or isosulfan blue demonstrate similar crossover rates to radiotracer identified sentinel 
nodes. J Surg Oncol. 2018;117(3):336-340. 
11. 
Noguchi M, Noguchi M, Nakano Y, Ohno Y, Kosaka T. Axillary reverse mapping using a 
fluorescence imaging system in breast cancer. J Surg Oncol. 2012;105(3):229-234. 
12. 
Noguchi M, Yokoi M, Nakano Y. Axillary reverse mapping with indocyanine fluorescence 
imaging in patients with breast cancer. J Surg Oncol. 2010;101(3):217-221. 
13. 
Sakurai T, Endo M, Shimizu K, et al. Axillary reverse mapping using fluorescence imaging is 
useful for identifying the risk group of postoperative lymphedema in breast cancer patients 
undergoing sentinel node biopsies. J Surg Oncol. 2014;109(6):612-615. 
14. 
Yuan Q, Wu G, Xiao SY, et al. Identification and Preservation of Arm Lymphatic System in 
Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized 
Clinical Trial. Ann Surg Oncol. 2019;26(11):3446-3454. 
15. 
Ma X, Wen S, Liu B, et al. Relationship between Upper Extremity Lymphatic Drainage and 
Sentinel Lymph Nodes in Patients with Breast Cancer. J Oncol. 2019;2019:8637895. 
16. 
AV DS, Lin H, Henderson ER, Samkoe KS, Pogue BW. Review of fluorescence guided surgery 
systems: identification of key performance capabilities beyond indocyanine green imaging. J 
Biomed Opt. 2016;21(8):80901. 
17. 
DeSantis CE, Ma J, Gaudet MM, et al. Breast cancer statistics, 2019. CA Cancer J Clin. 
2019;69(6):438-451. 
18. 
Shih YC, Xu Y, Cormier JN, et al. Incidence, treatment costs, and complications of lymphedema 
after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 
2009;27(12):2007-2014. 
19. 
McLaughlin SA, Bagaria S, Gibson T, et al. Trends in risk reduction practices for the prevention 
of lymphedema in the first 12 months after breast cancer surgery. J Am Coll Surg. 
2013;216(3):380-389; quiz 511-383. 
20. 
Wilke LG, McCall LM, Posther KE, et al. Surgical complications associated with sentinel lymph 
node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol. 
2006;13(4):491-500. 
21. 
Han JW, Seo YJ, Choi JE, Kang SH, Bae YK, Lee SJ. The efficacy of arm node preserving 
surgery using axillary reverse mapping for preventing lymphedema in patients with breast 
cancer. J Breast Cancer. 2012;15(1):91-97. 


 
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22. 
Suami H, Chagn D, Skoracki R, Yamada K, y. K. Using indocyanine green fluorescent 
lymphography to demonstrate lymphatic architecture. Journal of Lymphoedema. 2012;7(2):25-
29. 
23. 
Boni L, David G, Mangano A, et al. Clinical applications of indocyanine green (ICG) enhanced 
fluorescence in laparoscopic surgery. Surg Endosc. 2015;29(7):2046-2055. 
24. 
Abbaci M, Conversano A, Karimi M, et al. Near-Infrared Fluorescence Axillary Reverse Mapping 
(ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM 
Lymph Nodes and Clinical Outcomes. Cancers (Basel). 2022;14(11). 
25. 
Ikeda K, Ogawa Y, Kajino C, et al. The influence of axillary reverse mapping related factors on 
lymphedema in breast cancer patients. Eur J Surg Oncol. 2014;40(7):818-823. 
26. 
Ikeda K, Ogawa Y, Komatsu H, et al. Evaluation of the metastatic status of lymph nodes 
identified using axillary reverse mapping in breast cancer patients. World J Surg Oncol. 
2012;10:233. 
27. 
Guo J, Yang H, Wang S, et al. Comparison of sentinel lymph node biopsy guided by 
indocyanine green, blue dye, and their combination in breast cancer patients: a prospective 
cohort study. World J Surg Oncol. 2017;15(1):196. 
 

ICF_000.pdf: 
HS IRB #: 2020-0939 
Lead Researcher: Heather B. Neuman, 608-262-2025 
Version: 11/28/2022 
Page 0 of 8 
IRB Approval Date: 12/5/2022               
University of Wisconsin – Madison 
 
 
 
[Year] 
Intraoperative evaluation of axillary lymphatics for breast 
cancer patients undergoing axillary surgery 
NCT05094102      


HS IRB #: 2020-0939 
Lead Researcher: Heather B. Neuman, 608-262-2025 
Version: 11/28/2022 
Page 1 of 8 
IRB Approval Date: 12/5/2022               
University of Wisconsin – Madison 
University of Wisconsin-Madison 
Consent to Participate in Research 
and 
Authorization to Use Protected Health Information for Research 
Study Title for Participants: Intraoperative evaluation of axillary lymphatics for breast 
cancer patients undergoing axillary surgery 
Lead Researcher: Heather B. Neuman, MD, MS.  
Where Lead Researcher works: University of Wisconsin School of Medicine and 
Public Health 
______________________________________________________________________ 
Invitation 
We invite you to take part in a research study about how to better see lymph nodes and 
lymphatic channels under your arm during breast cancer treatment surgery. We are 
inviting you to participate because you have been diagnosed with breast cancer and will 
be undergoing an axillary lymph node surgery related to your breast cancer.    
The purpose of this consent and authorization form is to give you the information you 
need to decide whether you’d like to be in the study. It also explains how health 
information will be used for this study, and requests your authorization (permission) to 
use your health information. Please ask questions about anything in this form that is not 
clear. If you want to talk to your family and friends before making your decision, you 
can. Once we have answered all of your questions, you can decide whether or not you’d 
like to participate in this study. This process is called “informed consent.”   
Why are researchers doing this study? 
The purpose of this research study is to assess the feasibility of using fluorescence 
imaging through the Asimov Imaging Platform to perform “axillary reverse mapping” 
(ARM). Axillary reverse mapping is a way for your surgeon to see the lymphatic 
channels that travel from your arm. Saving those lymphatics may decrease your risk of 
developing lymphedema – or arm swelling – after surgery. Most surgeons use blue dye 
to guide axillary reverse mapping. Although the use of fluorescence imaging for axillary 
reverse mapping has been described in research studies, there are limitations with the 
currently available fluorescence-imaging platforms that make them difficult to use for 
this purpose. We are doing this research to test the feasibility of a new technology 


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platform (Asimov Imaging) that we think will address some of the limitations of prior 
techniques and improve our ability to perform axillary reverse mapping.  
This study is being done at the University of Wisconsin-Madison (UW-Madison). 
Approximately 25 people will participate.   
Funding for the Asimov Imaging Platform for this study is provided by the National 
Cancer Institute. The medical device company OnLume is providing the device to be 
used during this study. 
What will happen in this study? 
If you decide to participate in this research study, the researchers will ask you to sign 
and date this consent form. If you do not sign this consent form, you will continue to 
receive care, but not as part of this study. 
In this study, Dr. Neuman will perform axillary reverse mapping with isosulfan blue dye 
using standard procedures. This involves injecting the blue dye in the upper arm; the 
dye then will track into the lymphatic channels to mark where the lymphatic channels 
are that are draining the arm. Dr. Neuman will look for these lymphatic channels during 
surgery and try to save them, if possible. Dr. Neuman will make decisions during 
surgery using information from the blue dye alone. For patients who are also 
undergoing the sentinel lymph node biopsy for their cancer, the mapping of the breast 
lymphatics will be performed with the radioactive protein (technetium TC 99M sulfur 
colloid) alone; no blue dye would be used to map the lymphatics draining the breast.  
For this research, Dr. Neuman will also use indocyanine green (ICG) fluorescence dye 
during your surgery. She will inject the ICG fluorescence dye in the upper arm in the 
same location as the isosulfan blue dye as well as between your fingers. She will then 
image the axilla with the Asimov Imaging Platform to look for the lymphatics draining the 
arm. Dr. Neuman will collect information about whether the lymphatic channels draining 
from the arm were able to be seen, and whether they were seen by blue dye or the ICG 
fluorescence dye (or both or neither). She will also collect information related to the ICG 
fluorescence and the Asimov Imaging Platform. 
Demographic data (such as age and race), information about your tumor, and any later 
axillary surgeries or complications will also be collected from your medical record up to 
1 year after your surgery.   
Adding the ICG-fluorescence with the Asimov Imaging Platform may extend the length 
of your surgery by up to 20 minutes. 


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Protected health information (PHI) used in this study 
Protected health information, also called PHI, is information about your physical or 
mental health that includes your name or other information that can identify you, such 
as your date of birth or medical record number. To do this study, we will use the 
following kinds of PHI: 
 Results from tests or procedures done as part of the study. 
 Things you tell the researchers about your health. 
 Information currently in your medical record as well as information added to your 
medical record during the course of this study. This information could include 
demographics (such as age and race), type of axillary surgery, cancer stage and 
receptor status, and prior cancer treatments. Operative data will also be 
collected, such as the number of lymph nodes removed and whether the lymph 
nodes were radioactive, blue, or fluorescent.   
How long will I be in this study? 
Your active participation in the study will take place on one day (the day of your lymph 
node surgery). However, researchers may review your chart for up to 1 year after 
surgery.   
How is being in this study different from my regular health care? 
 People with breast cancer usually have axillary surgery as part of the cancer 
treatment. Axillary reverse mapping is a technique used by breast surgeons as a 
way to potentially decrease the risk of lymphedema resulting from the axillary 
surgery. It is most commonly used for patients undergoing an axillary lymph node 
dissection. The mapping is most commonly performed using blue dye (such as 
isosulfan blue).  
 In this study, patients will undergo either an axillary lymph node dissection or a 
sentinel lymph node biopsy per their surgeon’s recommendations. Patients will 
also undergo the axillary reverse mapping procedure. Axillary reverse mapping 
would be performed with both blue dye and ICG-fluorescence during the surgery.  
 If you take part in this study, the main difference between your regular care and the 
study is that the axillary reverse mapping procedure would definitely be 
performed. This procedure is performed sometimes in regular care. The other 
difference is that the axillary reverse mapping would be performed with both blue 
dye and ICG-fluorescence (most commonly done at the UW using just the blue 
dye). The Asimov Imaging Platform will be used to distinguish the arm vs. breast 
draining lymph nodes.  
 Using the indocyanine green (ICG) fluorescence with the Asimov Imaging Platform 
may lengthen your surgery by less than 20 minutes. 


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Do I have to be in the study?  What if I say “yes” now and change my 
mind later? 
No, you do not have to be in this study. Taking part in research is voluntary. This means 
that you decide if you want to be in the study. If you decide now to take part, you can 
choose to leave the study at any time. Let the researchers know if you choose to leave 
the study. 
If you decide not to take part in the study, or if you choose to leave the study, your 
choice will not affect any treatment relationship you have with your healthcare providers 
at UW-Madison, UW Health, or any affiliated organizations, or any services you receive 
from them. No matter what decision you make, and even if your decision changes, there 
will be no penalty to you. You will not lose medical care or any legal rights. 
Your authorization for researchers to use your protected health information (PHI) will 
last until the research study is complete. However: 
● You can choose to take back your authorization for researchers to use your 
health information. You can do this at any time before or during your 
participation in the study.  
● If you take back your authorization, information that was already collected 
may still be used and shared with others; however, the researchers will no 
longer be able to collect NEW information about you.   
● If you take back your authorization, you will not be able to take part in the 
research study. To take back your authorization, you will need to tell the Lead 
Researcher by writing to, Heather B. Neuman, K6/142 CSC, 600 Highland 
Ave, Madison, WI  53792-7375. 
What are my other choices if I do not take part in this study? 
You do not have to be in this research study to get care for your breast cancer. If you 
decide not take part in the study, you have other choices. For example, you may choose 
to get the regular care described above for breast cancer. 
Will being in this study help me in any way? 
You are unlikely to benefit directly from participation in this study.  However, your 
participation may help other people in the future by helping us learn more about how to 
best perform axillary surgery to decrease the risk of lymphedema.  
Will I receive the results of research tests? 
Information related to the ICG imaging is being collected for research purposes only and 
no imaging findings from the ICG fluorescence are being used to make clinical 


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decisions. Because the imaging can only visualize the lymphatics, it is unlikely that 
there will be any unexpected findings. Dr. Neuman will describe whether the lymphatics 
draining the arm were visible during the surgery upon your request.   
What are the risks? 
There is a risk that your information could become known to someone not involved in 
this study. There is a very small risk of an allergic reaction (1 in 42,000 people) to the 
ICG-fluorescent dye. An allergic reaction could range from something as small as hives 
to cough or difficulty swallowing. If you were to develop an allergic reaction, you would 
be treated with medicines in the operating room. Using the indocyanine green (ICG) 
fluorescence with the Asimov Imaging Platform may lengthen your surgery by less than 
20 minutes. Extension of the operation and the anesthesia represents no foreseeable 
risk to your health.  
Will being in this study cost me anything? 
● There will be no cost to you for any of the study activities or procedures.  
● You or your insurance company will have to pay for all costs for medical care 
related to your treatment for your breast cancer, including co-payments and 
deductibles. You will have to pay for any costs your insurance does not cover. If 
you have any questions about these costs, or what out-of-pocket expenses you 
may have, you should contact your insurance company. If you do not have health 
insurance, you will have to pay all costs for your medical care just as you would if 
you did not take part in this study.  
Will I be paid or receive anything for being in this study? 
● We will not pay you to take part in this study or pay for any out of pocket 
expenses related to your participation, such as travel costs. 
● Researchers may develop products from the information you provide for this 
study. Some of these products may have commercial value. If the research team 
or others use your information to develop products of commercial value, you will 
not receive any profits from products created from your samples or information. 
● A member of this research team has a personal interest in or might profit 
financially from the results of this study. This is called a “conflict of interest.” The 
University of Wisconsin-Madison manages conflicts of interest so that they do not 
affect study participants or the quality of the data collected. We are telling you 
about the conflict of interest in case it affects whether you want to take part in this 
study. 
What happens if I am injured or get sick because of this study? 


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If you are injured or get sick because of this study, medical care is available to you 
through UW Health, your local provider, or emergency services – as it is to all sick or 
injured people.  
 If it is an emergency, call 911 right away or go to the emergency room.  
 For non-emergency medical problems, contact the UW Breast Center.  
 Call the Lead Researcher, Dr. Heather Neuman, at 608-266-6400 to report your 
sickness or injury. 
Here are some things you need to know if you get sick or are injured because of this 
research:  
 If the sickness or injury requires medical care, the costs for the care will be billed to 
you or your insurance, just like any other medical costs.  
 Your health insurance company may or may not pay for this care. 
 No other compensation (such as lost wages or damages) is usually available. 
 UW-Madison and UW Health do not have a program to pay you if you get sick or 
are injured because of this study. 
 By signing this consent form and taking part in this study, you are not giving up any 
legal rights you may have. You keep your legal rights to seek payment for care 
required because of a sickness or injury resulting from this study.  
How will researchers keep my research information confidential?  
We have strict rules to protect your personal information and protected health 
information (PHI). We will limit who has access to your name, address, phone number, 
and other information that can identify you. We will also store this information securely.  
We may publish and present what we learn from this study, but none of this information 
will identify you directly without your permission. 
The study has a Certificate of Confidentiality from the National Institutes of Health (NIH). 
A Certificate of Confidentiality prohibits researchers from disclosing information or 
biospecimens that may identify you in a legal proceeding or in response to a legal 
request without your consent. 
However, we cannot promise complete confidentiality. Federal or state laws may permit 
or require us to show information to university or government officials and the National 
Cancer Institute responsible for monitoring this study. We may also have to tell 
appropriate authorities, such as child protective services or health care providers, if we 
learn during the study that you or others are at risk of harm (for example, due to child or 
elder abuse, or suicidal thoughts). 
Authorizing the research team to use your PHI means that we can release it to the 
people or groups listed below for the purposes described in this form. Once your health 


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information is released outside UW-Madison or UW Health it may not be protected by 
privacy laws and might be shared with others. Also, with appropriate institutional 
permissions and confidentiality protections, we might use information that we collect 
during this study for other research or share with other researchers without additional 
consent or authorization from you or your legally authorized representative.   
Who at UW-Madison can use my information? 
 Members of the research team  
 Offices and committees responsible for the oversight of research 
Who outside the UW-Madison may receive my information? 
 U.S. Office for Human Research Protections  
 The study sponsor, National Cancer Institute 
 Collaborating researchers outside UW-Madison, including researchers at 
OnLume, Inc. 
 OnLume Inc. will receive  participant data that is collected through the 
Asimov Imaging Platform.  
 The U. S. Food and Drug Administration (FDA) 
 A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law. This website will not include information that can 
identify you. At most, the website will include a summary of the results. You 
can search this website at any time. 
Will information from this study go in my medical record? 
 Some of the information we collect for this study will go in your medical record. 
This includes a description of the operative procedure in the medical record; 
this operative procedure will also state that you participated in the research 
study. Both you and your UW Health providers will be able to see these 
results. No imaging pictures will be added to your medical record. 
What if I have questions? 
If you have questions about this research, please contact the Lead Researcher, Dr. 
Heather B. Neuman, at 608-262-2025. If you have any questions about your rights as a 
research subject or have complaints about the research study or study team,  call the 
confidential research compliance line at 1-833-652-2506. Staff will work with you to 
address concerns about research participation and assist in resolving problems. 
Agreement to participate in the research study 


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You do not have to sign this form. If you refuse to sign, however, you cannot take part in 
this research study. 
If you sign the line below, it means that: 
● You have read this consent and authorization form. 
● You have had a chance to ask questions about the research study, and the 
researchers have answered your questions.    
● You want to be in this study. 
● You give authorization for your protected health information to be used and 
shared as described in this form. 
________________________________________________________________
______ Printed Name of Research Participant 
______________________________________________________________________ 
Signature of Research Participant 
Date 
______________________________________________________________________ 
Signature of Person Obtaining Consent and Authorization 
Date 
**You will receive a copy of this form**