RecruitingNot ApplicableNCT07441733

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

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

Sponsor

Casa di Cura Dott. Pederzoli

Enrollment

40 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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 Criteria6

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