Using indocyanine green to find sentinel lymph nodes during mastectomy
Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)
This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 2 sites (Zwolle, Overijssel and 1 other locations) |
| Trial ID | NCT07362485 on ClinicalTrials.gov |
What this trial studies
This multicenter pilot enrolls women with clinically node-negative, invasive T1–T3 breast cancer who are having a mastectomy with a sentinel lymph node procedure at St. Antonius or Isala Hospital. All participants receive the standard preoperative 99mTc injection, then 5 mg of indocyanine green (ICG) after anesthesia, and surgeons search for fluorescent sentinel nodes through the mastectomy incision without making a separate axillary cut. The primary outcome is the ICG detection rate of sentinel lymph nodes via the mastectomy incision. Secondary outcomes compare ICG with 99mTc detection, number and concordance of nodes found, pathology differences, detection time, and complications.
Who should consider this trial
Good fit: Women with biopsy-proven, clinically node-negative invasive T1–T3 breast cancer who are scheduled for mastectomy with a sentinel node procedure and can give informed consent are eligible.
Not a fit: Patients planning breast-conserving surgery, immediate reconstruction, with known allergy to ICG or technetium, with other concurrent solid tumors, or with clinically node-positive disease are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the technique could allow surgeons to locate sentinel nodes through the mastectomy incision without an extra axillary incision, potentially reducing additional incisions and operative burden.
How similar studies have performed: ICG-fluorescence for SLNB via a dedicated axillary incision has shown good diagnostic performance in prior work and is used clinically, but using only the mastectomy incision for ICG-guided detection is novel and not well described.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Zwolle, Overijssel and 1 other locations
- Isala — Zwolle, Overijssel, Netherlands (Recruiting)
- St. Antonius Ziekenhuis — Utrecht, Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Isabelle Henskens, MD
- Email: i.henskens@antoniusziekenhuis.nl
- Phone: +31883202902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.