VEGF Imaging in Renal Cell Carcinoma

NCT ID: NCT00831857

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-09-30

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.

Conditions

Renal Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Treatment with sunitinib.

89Zr-Bevacizumab PET-scan

Intervention Type: OTHER

At baseline, after two weeks of treatment and after 6 weeks of treatment.

Group B

Treatment with bevacizumab and interferon

89Zr-Bevacizumab PET-scan

Intervention Type: OTHER

At baseline, after two weeks of treatment and after 6 weeks of treatment.

Interventions

89Zr-Bevacizumab PET-scan

At baseline, after two weeks of treatment and after 6 weeks of treatment.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sjoukje F. Oosting, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

Renimage Protocol

Identifier Type: -

Identifier Source: org_study_id