Back to resultsICG and SLN Mapping
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
SLN mapping using technetium-99m +/- isosulfan blue dye
SLN mapping with ICG fluorescence using the Asimov Platform
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, sentinel lymph node, ICG fluorescence
Eligibility Criteria
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 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. Study team will exclude women who are breastfeeding. Unable to provide informed consent Allergy to indocyanine green History of ipsilateral breast or axillary surgery
Sites / Locations
- University of WisconsinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sentinel Lymph Node (SLN) mapping
Arm Description
SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Outcomes
Primary Outcome Measures
Concordance between detection of sentinel lymph nodes by ICG versus technetium-99, at the lymph node level
The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.
Concordance between detection of sentinel lymph nodes by ICG versus technetium-99, at the patient level
The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence.
Secondary Outcome Measures
Accuracy of the ICG mapping
Using the technetium-99as the gold standard, the study team 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.
Full Information
NCT ID
NCT05859971
First Posted
April 6, 2023
Last Updated
May 15, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
OnLume Inc., National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05859971
Brief Title
ICG and SLN Mapping
Official Title
Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
OnLume Inc., National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov Imaging Platform, to perform sentinel lymph node biopsy.
Participants in this research study will be undergoing a sentinel lymph node biopsy as part of surgical treatment for breast cancer. Active participation will last through the post-operative visit.
Detailed Description
In this study, the sentinel lymph node biopsy will be performed with radioactive tracer (technetium-99 sulfur colloid) and blue dye, which is standard of care. Decisions will be made during surgery about which lymph nodes to remove using information from the radioactive tracer and blue dye alone.
For this research, ICG fluorescence dye during participant's surgery will also be used. After anesthesia has started, the ICG fluorescence dye will be injected in the breast along at the edge of the areola in the same location as the radioactive tracer and blue dye injections. The breast and axilla will then be imaged with the Asimov Imaging Platform to look for the sentinel lymph nodes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, sentinel lymph node, ICG fluorescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sentinel Lymph Node (SLN) mapping
Arm Type
Experimental
Arm Description
SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
Intervention Type
Drug
Intervention Name(s)
SLN mapping using technetium-99m +/- isosulfan blue dye
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SLN mapping with ICG fluorescence using the Asimov Platform
Intervention Description
2 ml (5 mg) of ICG solution will be injected intradermally in 1-4 injection sites in the lateral areolar region. 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.
Primary Outcome Measure Information:
Title
Concordance between detection of sentinel lymph nodes by ICG versus technetium-99, at the lymph node level
Description
The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.
Time Frame
Day of operation
Title
Concordance between detection of sentinel lymph nodes by ICG versus technetium-99, at the patient level
Description
The study team will assess concordance rates at the patient level rates between technetium-99 and ICG-fluorescence.
Time Frame
Day of operation
Secondary Outcome Measure Information:
Title
Accuracy of the ICG mapping
Description
Using the technetium-99as the gold standard, the study team 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.
Time Frame
Day of operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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. Study team will exclude women who are breastfeeding.
Unable to provide informed consent
Allergy to indocyanine green
History of ipsilateral breast or axillary surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Breuer
Phone
608-262-7847
Email
breuer@surgery.wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Grace McKinney
Email
mckinney@surgery.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Neuman, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Breuer
Phone
608-262-7847
Email
breuer@surgery.wisc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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ICG and SLN Mapping
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