Clinical Trial: NCT06227338
ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
Status:
UNKNOWNPhase:
Not Applicable| Lead Sponsor: | Jules Bordet Institute |
| Information Provided By: | Jules Bordet Institute |
| Last Update Posted: | 2025-02-26 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Indocyanine green
Other Study ID Numbers
- IJB-S2022-IFIBC01
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Jules Bordet Institute |
| Information Provided By: | Jules Bordet Institute |
| Last Update Posted: | 2025-02-26 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Indocyanine green
Other Study ID Numbers
- IJB-S2022-IFIBC01