Renimage: VEGF Imaging in Renal Cell Carcinoma
Study Details
Study Description
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 with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after institution of treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 interferon.
-
To explore relationships between VEGF pathway related biomarkers and 89Zr-bevacizumab PET response.
-
To explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89Zr-bevacizumab PET response.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A Treatment with sunitinib. |
Other: 89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks of treatment.
|
| Group B Treatment with bevacizumab and interferon |
Other: 89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks of treatment.
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint is the change in SUV between baseline 89Zr-bevacizumab PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib or bevacizumab plus interferon in patients with RCC. [after 2 and 6 weeks]
Secondary Outcome Measures
- Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is defined as the appearance of new disease or an increase of 20% in the sum of the longest diameters of the target lesions. [3 months after treatment]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands | 9700 RB |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: Sjoukje F. Oosting, MD, University Medical Center Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Renimage Protocol