VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: UMC Utrecht
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Patients with proven breast cancer (cytology, histology) who are scheduled to receive operation intervention.

• Tumor size of at least 15 mm diameter according to anatomical imaging data.

• Signed written informed consent.

• Able to comply with the protocol.

• WHO performance score 0-2.

Exclusion Criteria:

• Other invasive malignancy.

• Serious other medical conditions.

• Pregnant or lactating women. (Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause).

• Prior radiotherapy on the involved area.

• Major surgery within 28 days before the initiation of the study.

• Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

• Prior neo-adjuvant chemotherapy.

• Breast prosthesis in target breast.

UMC Utrecht (FDOT) specific exclusion criteria

• Breast is too big to fit in the biggest cup or is too small to fit in the smallest cup of the FDOT system.

• Non-intact skin at time of the FDOT procedures.

• Breast located skin diseases.

• Piercings or tattoos located on the breast/nipple.

• Contra-indication for MR procedures or claustrophobia.

• Inability to lay prone positioned for the duration of the FDOT procedure (10 minutes) and MR procedure (30 minutes).

• Tumor located close to the chest wall as assessed by breast imaging data.