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ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study

NCT06227338 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-02-26

No results posted yet for this study

Summary

Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment.

Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm.

In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups.

In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.

Conditions

Interventions

DRUG

Indocyanine green

Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Florin Pop, MD · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Belgium

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 NCT06227338 on ClinicalTrials.gov