Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
Recruiting
N/A
Interventional Study
Breast Cancer
Sentinel Lymph Node Biopsy (SLNB)
Sentinel Lymph Node Detection
Sentinel Lymph Node
Lymphatic Metastasis
Fluorescence Imaging
Indocyanine Green (ICG)
Radioisotopes
Lymph Node Mapping
Mastectomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 90 (estimated)
- Sponsor
- Isabelle Henskens · Other
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About This 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 preopera…
Trial Locations
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Eligibility Criteria
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 I…
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