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

NCT07362485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-23

No results posted yet for this study

Summary

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

  • Breast Cancer
  • Sentinel Lymph Node Biopsy (SLNB)
  • Sentinel Lymph Node Detection
  • Sentinel Lymph Node
  • Lymphatic Metastasis
  • Fluorescence Imaging
  • Indocyanine Green (ICG)
  • Radioisotopes
  • Lymph Node Mapping
  • Mastectomy

Interventions

OTHER

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

ICG-fluorescence is used as the primary tracer to identify SLNs during SLNB in breast cancer surgery. The standard 99mTc-nanocolloid method is used as a control to verify the sentinel lymph nodes identified by ICG. Surgeons are blinded to preoperative lymphoscintigraphy results. After general anesthesia, 5 mg (2 mL of 2.5 mg/mL solutio) of ICG is injected sub-/intracutaneous periareolarly. ICG-fluorescence is detected using near-infrared imaging. SLNB via mastectomy incision is performed. The most fluorescent lymph node is excised first, followed by (maximal 2) additional fluorescent nodes. The excised nodes are tested for 99mTc-activity using a gamma probe. The axilla is then checked with the gamma probe and and palpation for any remaining nodes, which are excised if their radiation count exceeds 10% of the hottest node. All excised lymph nodes are sent for pathological examination to determine the presence of cancer cells. After surgery, the lymphoscintigraphy results are announced.

Sponsors & Collaborators

  • Isala

    collaborator OTHER

  • Isabelle Henskens

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362485 on ClinicalTrials.gov