Recruiting
Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
ClinicalTrials.gov IDNCT07441733
PhaseNA
Enrollment40
SponsorCasa di Cura Dott. Pederzoli
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Interventions
- Procedure: ICG used as a tracer for sentinel lymph node — ICG used as a tracer for sentinel lymph node instead of technetium 99
- Procedure: technetium 99 used as a tracer for sentinel lymph node — technetium 99 used as a tracer for sentinel lymph node instead of ICG
Primary outcomes
- Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG (through study completion, an average of 1 year)
Eligibility information
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
Study locations
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A., Peschiera del Garda, Verona Italy
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.