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Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer

RecruitingNAAges 18 Years - anyAllIsabelle Henskens
NCT07146295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dye called indocyanine green (ICG) and a special camera to see the lymph node. The sentinel lymph node is the first lymph node that cancer is likely to spread to. In the Netherlands, about 1 in 7 women develops breast cancer. Finding out whether cancer has spread to the lymph nodes is important for planning treatment and predicting outcomes. The current standard method for sentinel lymph node biopsy (SLNB) uses a radioactive tracer called radioisotope technetium-labeled (99mTc)-nanocolloid. While accurate, this method has several drawbacks: it exposes patients to radioactivity, requires an extra hospital visit or travel to another hospital due to limited nuclear medicine facilities, and is no

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Technetium (99mTc)
  • Indocyanine Green
  • Sentinel lymph node biopsy
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Where

7 sites
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuisgroep Twente
Hengelo, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Dijklander Ziekenhuis
Hoorn, Netherlands
Alrijne Hospital
Leiden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Diakonessenhuis
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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