89Zr-bevacizumab labelled PET imaging in patients with Renal Cell Carcinoma treated with sunitinib or bevacizumab plus interferon; a pilot study
- Conditions
- kidney cancer1003836410038430
- Registration Number
- NL-OMON33835
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
•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
•>= 18 years
•clear cell histology component
•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
Are formulated as no existence of in inclusion criteria
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the change in SUVmax between baseline 89Zr-bevacizumab<br /><br>PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib<br /><br>or bevacizumab plus interferon in patients with RCC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is progressive disease according to Response Evaluation<br /><br>Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment. </p><br>