Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

VEGF Imaging in Renal Cell Carcinoma (Renimage)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S.F. Oosting-Lenstra, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00831857
First received: January 28, 2009
Last updated: September 27, 2011
Last verified: September 2011

January 28, 2009
September 27, 2011
January 2009
September 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: after 2 and 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831857 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
VEGF Imaging in Renal Cell Carcinoma
89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study

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.

  • 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients locally advanced irresectable or metastatic renal cell cancer.

Renal Cell Carcinoma
Other: 89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks of treatment.
  • Group A
    Treatment with sunitinib.
    Intervention: Other: 89Zr-Bevacizumab PET-scan
  • Group B
    Treatment with bevacizumab and interferon
    Intervention: Other: 89Zr-Bevacizumab PET-scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00831857
Renimage Protocol
No
S.F. Oosting-Lenstra, University Medical Centre Groningen
University Medical Centre Groningen
Not Provided
Principal Investigator: Sjoukje F. Oosting, MD University Medical Centre Groningen
University Medical Centre Groningen
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP