Status:
COMPLETED
VEGF Early Imaging for Breast Cancer
Lead Sponsor:
University Medical Center Groningen
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Breast cancer is the most common cause of cancer death among women. Yearly around 12,500 Dutch women are diagnosed with breast cancer and 3,500 die of this disease. One of the problems leading to such...
Detailed Description
Objectives of the trial Primary objective The aim is to perform a feasibility study to show that VEGF PET imaging using 89Zr-bevacizumab as tracer can be used for early breast cancer detection. Seco...
Eligibility Criteria
Inclusion
- Patients with a breast tumor size \< 2 cm in diameter (as determined by means of conventional imaging techniques: mammography, ultrasound or MRI) who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy.
- histologically proven breast cancer
- Age \> 18 years.
- WHO performance status 0-2 (see: appendix B)
- Signed written informed consent (approved by the Institutional Review Board \[IRB\]/ Independent Ethics Committee \[IEC\]) obtained prior to any study specific screening procedures.
- Able to comply with the protocol.
Exclusion
- Other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
- 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.
- Clinically significant cardiovascular disease.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00991978
Start Date
March 1 2010
End Date
January 1 2012
Last Update
March 30 2012
Active Locations (1)
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1
Universitar Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ