Status:
COMPLETED
VEGF Imaging in Renal Cell Carcinoma
Lead Sponsor:
University Medical Center Groningen
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients w...
Detailed Description
* To explore if 89Zr-bevacizumab PET imaging can differentiate RCC patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus inte...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- locally advanced irresectable or metastatic renal cell cancer
- no untreated brain metastases (CT or MRI not necessary in the absence of symptoms)
- no uncontrolled hypertension
- no clinically significant cardiovascular events or disease during the last 12 months
- no surgery in the last 4 weeks
- no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
- no treatment with a tyrosine kinase inhibitor during the last 4 weeks
- measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray \> 20 mm, Spiral CT scan \> 10 mm, non-spiral CT scan \> 20 mm
- clear cell histology component
- not pregnant or nursing
- women of childbearing potential must use effective contraception
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- before patient randomization, written informed consent must be given according to GCP, and local regulations
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00831857
Start Date
January 1 2009
End Date
September 1 2011
Last Update
May 6 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9700 RB