Fluorescence Guided Surgery in Breast Cancer

Sponsor
University Medical Center Groningen
Study ID
NCT02583568
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab-800CW — DRUG
    three days prior to surgery bevacizumab-800CW will be administered

Study Details

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.

Key Dates

First listed
Oct 22, 2015
Start date
Oct 31, 2015
Status verified
Feb 2017
Primary completion
Jan 31, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part 1
    In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
  • Experimental: Part 2
    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.

Primary Outcome Measure

Tumor-to-background ratio [ Time Frame: day 3 ]

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