A Phase 1/2 interventional study of Bevacizumab-800CW in Breast Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-13.
Sponsored by University Medical Center Groningen · Phase 1/2, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 26 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
In the Investigator's opinion, patient is able and willing to comply with all trial requirements.
For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
Main Exclusion Criteria:
In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
Drug: Bevacizumab-800CW
In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group.
Drug: Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Also known as: Bevacizumab-IRDye800CW
Tumor-to-background ratio
Time frame: day 3
Number of participants with treatment-related adverse events
Time frame: up to two weeks
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen