Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)

Recruiting · NCT07362485 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy

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.

Who can take part

Age range

18 Years and older

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

2 locations listed.

Isala - Zwolle, Overijssel, Netherlands
St. Antonius Ziekenhuis - Utrecht, Utrecht, Netherlands

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →