ICG and SLN Mapping

Breast Cancer Clinical Trial

Official title:

Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05859971
• Other study ID #: 2023-0030
• Secondary ID: 5R44CA206754UW22
• Status: Completed
• Phase: Early Phase 1
• Start date: April 13, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI), OnLume Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Day of operation