Sentinel Lymph Node Mapping in Breast Cancer Patients Through Fluorescent Imaging Using Indocyanine Green: The INFLUENCE Trial

Phase 4

Completed

Conditions: <p>Breast cancer</p>
10006295

Registration Number: NL-OMON29593

Lead Sponsor: St. Antonius Hospital

Brief Summary: Objective: The aim was to compare the (sentinel) lymph node detection rate of indocyanine green (ICG)-fluorescent imaging versus standard-of-care 99m Tc-nanocoilloid for sentinel lymph node (SLN)-mapping. Background: The current gold standard for axillary staging in patients with breast cancer is sentinel lymph node biopsy (SLNB) using radio-guided surgery using radioisotope technetium ( 99m Tc), sometimes combined with blue dye. A promising alternative is fluorescent imaging using ICG. Methods: In this noninferiority trial, we enrolled 102 consecutive patients with invasive early-stage, clinically node-negative breast cancer. Patients were planned for breast conserving surgery and SLNB between August 2020 and June 2021. The day or morning before surgery, patients were injected with 99m Tc-nanocolloid. In each patient, SLNB was first performed using ICG-fluorescent imaging, after which excised lymph nodes were tested with the gamma-probe for 99m Tc-uptake ex vivo, and the axilla was checked for residual 99m Tc-activity. The detection rate was defined as the proportion of patients in whom at least 1 (S)LN was detected with either tracer. Results: In total, 103 SLNBs were analyzed. The detection rate of ICG-fluorescence was 96.1% [95% confidence interval (95% CI)=90.4%-98.9%] versus 86.4% (95% CI=78.3%-92.4%) for 99m Tc-nanocoilloid. The detection rate for pathological lymph nodes was 86.7% (95% CI=59.5%-98.3%) for both ICG and 99m Tc-nanocoilloid. A median of 2 lymph nodes were removed. ICG-fluorescent imaging did not increase detection time. No adverse events were observed. Conclusions: ICG-fluorescence showed a higher (S)LN detection rate than 99m Tc-nanocoilloid, and equal detection rate for pathological (S)LNs. ICG-fluorescence may be used as a safe and effective alternative to 99m Tc-nanocoilloid for SLNB in patients with early-stage breast cancer."

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 102

Inclusion Criteria

- Clinically node-negative, invasive early T1 or T2 breast cancer confirmed by biopsy. - Preoperative axillary ultrasound to confirm clinical node-negative status. - Indication for lumpectomy and SLN procedure. - Written informed consent according to ICH/GCP and national regulations.

Exclusion Criteria

- Patients < 18 years old. - Mastectomy. - Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc) or intravenous contrast, iodine, shellfish. - Other concurrent or history of other solid tumor. - Hyperthyroidism or thyroid cancer. - T3 breast cancer confirmed by biopsy. - Palliative surgery for locally advanced breast cancer (cT4). - Pregnancy or breast feeding. - Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol.