Active — Not RecruitingNot Applicable

Identification of Sentinel Lymph Nodes Using Indocyanine Green in Breast Cancer Patients

Italy, Netherlands493 participantsStarted 2023-06-08

Plain-language summary

This study aims to evaluate the (inter)national implementation of a new diagnostic method for sentinel lymph node (SLN) detection in breast cancer. While Technetium-99m (99mTc) is the current gold standard for SLN detection, it has drawbacks such as limited availability, logistical challenges, radiation exposure, and potential side effects. Extensive research indicates that Indocyanine Green (ICG) is an equally effective and potentially more practical alternative. Conducting this study will help accelerate the implementation of ICG in clinical practice.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinically node-negative, DCIS or invasive 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 ICH/GCP and national regulations. Exclusion Criteria: * Patients \< 18 years old. * Indication for breast cancer surgery with SLNB via mastectomy incision * Combined MARI procedure * Known allergy for Indocyanine Green (ICG) or intravenous contrast or iodine * History of axillary lymph node dissection * Hyperthyroidism or thyroid cancer * Pregnancy or breast-feeding * Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol

What they're measuring

Identifaction rate

Timeframe: Perioperatively

Trial details

NCT IDNCT07311278

SponsorSt. Antonius Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

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