Using indocyanine green to find sentinel lymph nodes during mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.