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

NCT07362485 | Recruiting

• 1 other identifier: NL80591.100.22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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); Radioisotopes; Sentinel Lymph Node Detection; Sentinel Lymph Node; Lymphatic Metastasis; Fluorescence Imaging; Indocyanine Green (ICG); Lymph Node Mapping; Mastectomy

Keywords

Breast cancer; Sentinel lymph node biopsy; Indocyanine green; Mastectomy; Fluorescence imaging; Lymph node mapping; Surgical oncology; Techetium nanocolloïd; Radioisotope

Outcome Measures

Primary Outcomes (1)

• Identification rate of sentinel lymph nodes using indocyanine green fluorescence

  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.

  During the surgical procedure (from skin incision to completion of sentinel lymph node resection)

Secondary Outcomes (10)

• Identification rate of sentinel lymph nodes using 99mTc

  During the surgical procedure (from skin incision to completion of sentinel lymph node resection)

• Difference in sentinel lymph node detection rate between ICG and 99mTc

  During the surgical procedure (from skin incision to completion of sentinel lymph node resection)

• Number of sentinel lymph nodes identified per participant by ICG and 99mTc

  During the surgical procedure (from skin incision to completion of sentinel lymph node resection)

• Proportion of participants with fluorescent sentinel lymph nodes among those identified by 99mTc

  During the surgical procedure (from skin incision to completion of sentinel lymph node resection)

• Fluorescent sentinel lymph nodes not positive for 99mTc

  During the surgical procedure (from skin incision to completion of sentinel lymph node resection)

Study Arms (1)

ICG-fluorescence imaging with 99mTc control for SLNB

EXPERIMENTAL

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.

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

Interventions

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

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.

ICG-fluorescence imaging with 99mTc control for SLNB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isabelle Henskens: lead
• Isala: collaborator

Study Sites (2)

Isala

Zwolle, Overijssel, 8025 AB, Netherlands

RECRUITING

St. Antonius Ziekenhuis

Utrecht, Utrecht, 3543 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Isabelle Henskens, MD

CONTACT

+31883202902; i.henskens@antoniusziekenhuis.nl

Annemiek Doeksen, MD, PhD

CONTACT

+3183202900; a.doeksen@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating investigator

Model Details: All participants receive both indocyanine green (ICG) fluorescence imaging and standard 99mTc-nanocolloid sentinel lymph node mapping during the same surgical procedure. The procedure is primarily performed using ICG fluorescence imaging, with 99mTc serving as the control method to assess the diagnostic performance of ICG compared to 99mTc. Each patient serves as her own control in this within-subject comparison.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 23, 2026
• Study Start: August 22, 2022
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

NL (2)