drugset / Trial / NCT02583568
Fluorescence Guided Surgery in Breast Cancer
Phase 1/2
Completed
26 enrolled
University Medical Center Groningen
Martini Hospital Groningen · collab
Non-randomizedParallel-groupOpen-labelDiagnostic
Summary
A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.
Timeline
- Start
- 2015-10
- Primary completion
- 2017-01
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab-800CW | Diagnostic / imaging agent | 4 mg | — |
| Subject | Bevacizumab-800CW | Diagnostic / imaging agent | 5 mg | — |
| Subject | Bevacizumab-800CW | Diagnostic / imaging agent | 10 mg | — |
| Subject | Bevacizumab-800CW | Diagnostic / imaging agent | 25 mg | — |
| Subject | Bevacizumab-800CW | Diagnostic / imaging agent | 50 mg | — |