VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer
NCT01508572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-10-27
Summary
The purpose of this study is to determine the uptake, (semi-)quantification and localization of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue, surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW is assessed. Another purpose is to assess the abilities of three different fluorescent signal detection systems to detect the fluorescent signal pre- and intra-operatively.
Conditions
Interventions
- DRUG
-
bevacizumab-IRDye800CW
In this two stage, non-randomized, non-blinded, prospective, multicenter feasibility study, bevacizumab-IRDye800CW will be administered to a total of 20 patients with proven breast cancer.
Sponsors & Collaborators
-
UMC Utrecht
collaborator OTHER -
University Medical Center Groningen
lead OTHER
Principal Investigators
-
Go M. van Dam, MD, PhD · University Medical Center Groningen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2014-11-30
- Completion
- 2015-01-31
Countries
- Netherlands
Study Locations
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