Trials / Completed
CompletedNCT02583568
Fluorescence Guided Surgery in Breast Cancer
Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bevacizumab-800CW | three days prior to surgery bevacizumab-800CW will be administered |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-01-01
- Completion
- 2017-02-01
- First posted
- 2015-10-22
- Last updated
- 2017-02-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02583568. Inclusion in this directory is not an endorsement.