VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer

Sponsor
University Medical Center Groningen
Study ID
NCT01508572
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab-IRDye800CW — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 12, 2012
Start date
Oct 31, 2011
Status verified
Oct 2017
Primary completion
Nov 30, 2014
Completion
Jan 31, 2015

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

The uptake of bevacizumab-IRDye800CW in breast cancer tissue, surrounding tissue and lymph nodes in surgical specimens by fluorescence microscopy and macroscopy [ Time Frame: After the last patient is included, which is expected to be within one year after the first inclusion ]

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