Everolimage. 89Zr-bevacizumab PET imaging in patients with Renal Cell Carcinoma treated with everolimus; a pilot study.
- Conditions
- kidney cancerrenal cell carcinoma1003836310038430
- Registration Number
- NL-OMON36512
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
•metastatic renal cell cancer with
•Intention to start treatment with everolimus
•WHO performance score <= 2
•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
•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
Are formulated as no existence ofin inclusion criteria
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is change in 89Zr-bevacizumab uptake in tumor lesions<br /><br>between the baseline scan and the scan during treatment.</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.<br /><br>Progression is defined as the appearance of new disease or an increase of 20%<br /><br>in the sum of the longest diameters of the target lesions.</p><br>