Overview

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.