Last reviewed · How we verify
NCT06227338: BREASTIFLU-1
ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
NA trial testing Indocyanine green in Breast Cancer in 250 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Jules Bordet Institute |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 12 February 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Indocyanine green (INDOCYANINE GREEN) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Jules Bordet Institute
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Pop CF, Veys I, Moreau M, Paesmans M, et al · · 2026 · PMID 41772708 · DOI 10.1186/s13063-026-09577-8
Verify or expand the search:
- PubMed search for NCT06227338
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Indocyanine green
Trials testing the same drug.
- NCT06164392 — Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography · Phase 4 · withdrawn
- NCT06169735 — Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation · Phase 4 · recruiting
- NCT06322862 — FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery · NA · recruiting
- NCT06939946 — Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI) · Phase 1 · terminated
- NCT06398028 — The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resect · Phase 4 · recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Jules Bordet Institute trials
Trials by the same sponsor.
- NCT07455331 — Flash Radiotherapy for Skin Cancer · Phase 2 · not yet recruiting
- NCT07431346 — Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy · NA · not yet recruiting
- NCT06925984 — Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro- · NA · recruiting
- NCT06523634 — Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy. · NA · recruiting
- NCT05487248 — A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06227338 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jules Bordet Institute
- Last refreshed: 26 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06227338.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing