VEGF Imaging in Renal Cell Carcinoma (Renimage)

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Renal Cell Carcinoma

Treatments

Other: 89Zr-Bevacizumab PET-scan

Study type

Observational

Funder types

Other

Identifiers

NCT00831857

Renimage Protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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