Vascular Endothelial Growth Factor (VEGF) Imaging Before and During Everolimus Treatment for Renal Cell Carcinoma (Everolimage)
Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in patients.
The investigators hypothesize that a decline in VEGF early during everolimus treatment in patients with metastatic renal cell carcinoma predicts treatment efficacy.
89Zr-bevacizumab PET scans will be performed at baseline, after 2 and 6 weeks of everolimus treatment in 14 adult patients with metastatic renal cell carcinoma.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Everolimus; a Pilot Study|
- Change in 89Zr-bevacizumab uptake in tumor lesions between the baseline scan and the scan during treatment [ Time Frame: Baseline, 2 weeks and 6 weeks ] [ Designated as safety issue: No ]
- Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, white blood cells, plasma, serum, urine
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Renal Cancer patients treated with everolimus
Other: 89Zr-bevacizumab PET scan
A tracer dose of 89Zr-bevacizumab (37 MBq, 5 mg protein dose) is given intravenously at day -3, day 11 and day 39.
PET scans are made on day 1, day 15 and day 43.
Other Name: VEGF imaging
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01028638
|Contact: Sjoukje Oosting, MD||+ 31 50 email@example.com|
|Contact: Jourik Gietema, MD PhD||+31 50 firstname.lastname@example.org|
|University Medical Centre Groningen||Recruiting|
|Groningen, Netherlands, 9700 RB|
|Principal Investigator: Sjoukje Oosting, MD|
|Principal Investigator:||Sjoukje Oosting, MD||University Medical Centre Groningen|