Status:
COMPLETED
VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
UMC Utrecht
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 health...
Detailed Description
There is a need for better visualization of presence and extent of breast cancer to improve breast cancer management. Molecular imaging of breast cancer associated targets is a promising method to imp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01508572
Start Date
October 1 2011
End Date
January 1 2015
Last Update
October 27 2017
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ