VEGF Imaging in Renal Cell Carcinoma

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Other: 89Zr-Bevacizumab PET-scan

• Registration Number: NCT00831857
• Lead Sponsor: University Medical Center Groningen

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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	89Zr-Bevacizumab PET-scan	Treatment with sunitinib.
Group B	89Zr-Bevacizumab PET-scan	Treatment with bevacizumab and interferon

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands