Indocyanine green for sentinel lymph node mapping in breast cancer
Official title: INFLUENCE II - a Pilot Study for Implementation Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively FLUorEsceNt Imaging Using indoCyaninE Green: a Pilot Study for Implementation
Run by Casa di Cura Dott. Pederzoli · NCT07441733 · Data updated 2026-11-12
This pilot tests whether indocyanine green (ICG) fluorescent imaging can be used for sentinel lymph node mapping in people with clinically node-negative breast cancer instead of or alongside technetium (99mTc).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Casa di Cura Dott. Pederzoli Academic / other |
| Locations | 1 site (Peschiera del Garda, Verona) |
| Status | Recruiting |
| Started | November 7, 2024 |
| Main results expected | March 31, 2025 |
| Study ends | October 2026 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT07441733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with biopsy-confirmed DCIS or invasive T1–T3 breast cancer who are clinically node-negative on preoperative axillary ultrasound and scheduled for breast surgery with sentinel lymph node biopsy via an axillary incision who can give informed consent are ideal candidates.
✕Probably not a fit
Patients requiring SLNB via a mastectomy incision, those with prior axillary lymph node dissection, known allergy to ICG/iodine, pregnant or breastfeeding individuals, or those unable to comply with the protocol are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-institution pilot uses a pre- and post-implementation design to compare the standard 99mTc-nanocolloid sentinel node procedure with ICG fluorescence guidance. During a transition period participating surgeons receive on-site training, proctoring, and ongoing support from experienced ICG users before full implementation. After implementation, 5 mg (2 ml) ICG will be injected periareolarly under general anesthesia and sentinel nodes visualized with a fluorescence camera; outcomes including SLN identification rate, number of nodes removed, detection time, operative time, complications, and one-year loco-regional recurrence will be recorded. The study also collects surgeon expectations and post-implementation experiences to identify barriers and success factors for adopting ICG.
Why it matters
Potential benefit: If successful, ICG could simplify and speed up sentinel node mapping and reduce reliance on radioactive tracers, benefiting patients and surgical workflow.
How similar studies have gone: Multiple single-center and multicenter reports have shown that ICG fluorescence often achieves SLN detection rates comparable to technetium and can be a viable non-radioactive alternative.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy * Preoperative axillary ultrasound to confirm clinical node-negative status * Indication for breast cancer surgery with SLNB via axillar incision * Written informed consent according to national regulations Exclusion Criteria: * Patients \< 18 years old. * Indication for breast cancer surgery with SLNB via mastectomy incision * Known allergy for ICG, intravenous contrast or iodine * History of axillary lymph node dissection * Pregnancy or breast-feeding * Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
Where it's running
-
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.