Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 discomfort or visits. Risks and burden are minimal.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rak piersi w stadium T1-T3, potwierdzony biopsją, bez powiększonych węzłów chłonnych
- •Badanie ultrasonograficzne pachwin przed operacją potwierdzające brak powiększonych węzłów
- •Planowana całkowita mastektomia (usunięcie piersi) z badaniem węzła wartownika
- •Pisemna zgoda na uczestnictwo w badaniu
✗ Disqualifies
- •Wiek poniżej 18 lat
- •Operacja oszczędzająca pierś (plastyka piersi)
- •Alergia na barwnik używany w badaniu węzłów lub kontrast zawierający jod
- •Inne nowotwory złośliwe w organizmie
- •Nadczynność tarczycy lub rak tarczycy
- •Ciąża lub karmienie piersią
- •Problemy psychiczne, rodzinne, społeczne lub geograficzne mogące utrudnić uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- January 23, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Isala
Zwolle, Netherlands
St. Antonius Ziekenhuis
Utrecht, Netherlands
Trial contact
Isabelle Henskens, MD
Annemiek Doeksen, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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