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Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)

RecruitingNAAges 18 Years - anyFemaleIsabelle Henskens
NCT07362485 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients. Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision. Primary outcome: ICG detection rate for SLN identification via the mastectomy incision. Secondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications. ICG is safe, non-ionizing, and causes no extra discomf

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📋 Eligibility rules (as published)
Inclusion Criteria: * Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy. * Preoperative axillary ultrasound to confirm clinical node-negative status. * Indication (or preference) for mastectomy and simultaneous SLN procedure. * Written informed consent according to ICH/GCP and national regulations. Exclusion Criteria: * Patients \< 18 years old * Breast conserving surgery * Direct reconstruction (with autologous tissue or implant) * Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine * Other concurrent solid tumour * Hyperthyroidism or thyroid cancer * Pregnancy or breast feeding * Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
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What it tests

  • Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy
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Where

2 sites
Isala
Zwolle, Netherlands
St. Antonius Ziekenhuis
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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