Early Phase 1
N=10
ICG and SLN Mapping
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05859971 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level — 100 percent concordance
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- SLN mapping using technetium-99m +/- isosulfan blue dye (Drug); SLN mapping with ICG fluorescence using the Asimov Platform (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level |
100 | — |
| PRIMARY Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level |
100 | — |
| SECONDARY Accuracy of the ICG Mapping |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05859971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.