Actively Recruiting
Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
Led by Isabelle Henskens · Updated on 2026-01-23
90
Participants Needed
2
Research Sites
197 weeks
Total Duration
On this page
Sponsors
I
Isabelle Henskens
Lead Sponsor
I
Isala
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically node-negative, DCIS, invasive T1-T3 breast cancer confirmed by biopsy
- Preoperative axillary ultrasound confirming clinical node-negative status
- Planned mastectomy with simultaneous sentinel lymph node biopsy procedure
- Ability and willingness to provide written informed consent according to regulations
You will not qualify if you...
- Younger than 18 years old
- Undergoing breast conserving surgery
- Planned direct breast reconstruction with autologous tissue or implant
- Known allergy to indocyanine green (ICG), technetium (99mTc), intravenous contrast, or iodine
- Having another concurrent solid tumor
- History of hyperthyroidism or thyroid cancer
- Pregnant or breastfeeding
- Psychological, family, social, or geographic factors that may affect study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Isala
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
2
St. Antonius Ziekenhuis
Utrecht, Utrecht, Netherlands, 3543 AZ
Actively Recruiting
Research Team
I
Isabelle Henskens, MD
CONTACT
A
Annemiek Doeksen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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