ICG and SLN Mapping

NCT05859971 | Completed Early Phase 1 Results FDA Device

• 5 other identifiers: 2023-00305R44CA206754UW22145SMPH/SURGERY/SURG ONCProtocol Version 11/29/2022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; sentinel lymph node; ICG fluorescence

Outcome Measures

Primary Outcomes (2)

• 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.

  Day of operation

• 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.

  Day of operation

Secondary Outcomes (1)

• Accuracy of the ICG Mapping

  Day of operation

Study Arms (1)

Sentinel Lymph Node (SLN) mapping

EXPERIMENTAL

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

Drug: SLN mapping using technetium-99m +/- isosulfan blue dye; Device: SLN mapping with ICG fluorescence using the Asimov Platform

Interventions

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

Sentinel Lymph Node (SLN) mapping

SLN mapping with ICG fluorescence using the Asimov Platform 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.

Sentinel Lymph Node (SLN) mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• OnLume Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Difficult to differentiate general staining of the tissue from the ICG versus true residual fluorescence in a lymph node.

Results Point of Contact

• Title: Heather Neuman, MD, MS, FACS
• Organization: University of Wisconsin School of Medicine and Public Health

neuman@surgery.wisc.edu

(608) 262-9060

Study Officials

• Heather Neuman, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 16, 2023
• Study Start: April 13, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 29, 2025
• Results First Posted: August 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)