Status:
RECRUITING
Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer
Lead Sponsor:
Isabelle Henskens
Collaborating Sponsors:
Canisius-Wilhelmina Hospital
Spaarne Gasthuis
Conditions:
Breast Cancer
Sentinel Lymph Node Biopsy (SLNB)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn how to successfully introduce a new method for finding the sentinel lymph node during breast cancer surgery into routine hospital care. The method uses a dy...
Detailed Description
Background: Breast cancer affects one in seven women. Detecting lymph node metastases via the sentinel lymph node biopsy (SLNB) is crucial for prognosis and treatment. The gold standard is radio-guid...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old.
- DCIS or invasive breast cancer, confirmed by biopsy
- Clinically node-negative, confirmed by preoperative axillary ultrasound
- Indication for breast cancer surgery with SLN procedure via axillar incision
Exclusion
- Combined MARI procedure
- Known allergy for Indocyanine Green (ICG), intravenous contrast or iodine
- History of axillary lymph node dissection
- Hyperthyroidism or thyroid cancer
- Pregnancy or breast-feeding
- No written informed consent according to ICH/GCP and national regulations.
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
1760 Patients enrolled
Trial Details
Trial ID
NCT07146295
Start Date
April 18 2025
End Date
August 1 2026
Last Update
August 28 2025
Active Locations (7)
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1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
2
Ziekenhuisgroep Twente
Hengelo, Netherlands
3
Spaarne Gasthuis
Hoofddorp, Netherlands
4
Dijklander Ziekenhuis
Hoorn, Netherlands