Clinical trial · Interventional
Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fluorescence Imaging | — | UNRESOLVED | — |
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
| Lymphatic Metastasis | — | UNRESOLVED | — |
| Lymph Node Mapping | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Radioisotopes | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG-fluorescence imaging with 99mTc control for SLNB
- description
- This experimental arm involves participants receiving indocyanine green (ICG) fluorescence imaging as the primary method for sentinel lymph node biopsy (SLNB), with 99mTc-nanocolloid serving as the within-patient control. Both methods are applied during the same surgical procedure. This design allows each participant to serve as their own control for comparing the diagnostic perfomance of both techniques directly in indentifying sentinel lymph nodes via mastectomy incision.
- interventionNames
- Other: Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy
Primary outcomes (1)
- measure
- Identification rate of sentinel lymph nodes using indocyanine green fluorescence
- timeFrame
- During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
- description
- The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node (SLN) is successfully identified using indocyanine green (ICG) fluorescence imaging via the mastectomy incision during surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available