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

Timeline

Start

2024-02-12

Primary completion

2026-01-01

Completion

2026-01-01

Publications

• Pop CF, Veys I, Moreau M, Paesmans M, De Azambuja E, Larsimont D, Liberale G. Intraoperative breast cancer margin evaluation using fluorescence imaging with intravenous injection of indocyanine green (BREASTIFLU-1): study protocol for a randomized diagnostic accuracy trial of quantitative dose-timing assessment. Trials. 2026 Mar 3;27(1):288. doi: 10.1186/s13063-026-09577-8.

Drugs

Indications