Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07441733

Run by

Casa di Cura Dott. Pederzoli

People needed

40

Starts

2024-11-07

Expected to finish

2026-10-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda, Verona, Italy (enrolling)

Full record on ClinicalTrials.gov

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