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ICG-fluorescence imaging for intraoperative breast cancer margins evaluation: a dose-timing study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504024-26-00
Acronym
IJB-IFIBC-2022/01
Enrollment
250
Registered
2023-12-15
Start date
2024-02-09
Completion date
Unknown
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with primary invasive early breast cancer (T1-T2) that will undergo planned breast-conserving surgery

Brief summary

Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins

Detailed description

Comparison of ICG-FI technique accuracy at different doses and timing, Characterization of the breast tumor fluorescence (tumor-to-background fluorescence ratio), Evaluation of fluorescence intensity of axillary lymph nodes

Interventions

DRUGINDOCYANINE GREEN

Sponsors

Institut Jules Bordet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins

Secondary

MeasureTime frame
Comparison of ICG-FI technique accuracy at different doses and timing, Characterization of the breast tumor fluorescence (tumor-to-background fluorescence ratio), Evaluation of fluorescence intensity of axillary lymph nodes

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 4, 2026