Clinical trial · Interventional
ICG and SLN Mapping
Use of ICG-fluorescent Imaging for Sentinel Lymph Node Mapping in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLN mapping using technetium-99m +/- isosulfan blue dye | Drug | — | UNRESOLVED |
| SLN mapping with ICG fluorescence using the Asimov Platform | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node (SLN) mapping
- description
- SLN mapping and biopsy will be performed using technetium-99m sulfur colloid and isosulfan blue dye, as well as ICG-fluorescent imaging.
- interventionNames
- Drug: SLN mapping using technetium-99m +/- isosulfan blue dye
- Device: SLN mapping with ICG fluorescence using the Asimov Platform
Primary outcomes (2)
- measure
- Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Lymph Node Level
- timeFrame
- Day of operation
- description
- The study team will describe concordance rates between technetium-99 and ICG-fluorescence for each sentinel lymph node removed.
- measure
- Concordance Between Detection of Sentinel Lymph Nodes by ICG Versus Technetium-99, at the Patient Level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available