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

RECRUITINGN/ASponsored by Casa di Cura Dott. Pederzoli
Actively Recruiting
PhaseN/A
SponsorCasa di Cura Dott. Pederzoli
Started2024-11-07
Est. completion2025-03-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07441733

Summary

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

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