ICG and SLN Mapping

NCT ID: NCT05859971

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2023-06-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sentinel Lymph Node (SLN) mapping

SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.

Group Type: EXPERIMENTAL

SLN mapping using technetium-99m +/- isosulfan blue dye

Intervention Type: DRUG

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.

SLN mapping with ICG fluorescence using the Asimov Platform

Intervention Type: DEVICE

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.

Interventions

SLN mapping using technetium-99m +/- isosulfan blue dye

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: DRUG

SLN mapping with ICG fluorescence using the Asimov Platform

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OnLume Inc.

INDUSTRY

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Neuman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R44CA206754

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UW22145

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/SURGERY/SURG ONC

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 11/29/2022

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0030

Identifier Type: -

Identifier Source: org_study_id