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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00831857
Other study ID # Renimage Protocol
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2009
Est. completion date September 2011

Study information

Verified date May 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks of treatment.

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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