VEGF Imaging in Renal Cell Carcinoma (Renimage)

This study has been completed.
Information provided by (Responsible Party):
S.F. Oosting-Lenstra, University Medical Center Groningen Identifier:
First received: January 28, 2009
Last updated: October 1, 2015
Last verified: October 2015
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.

Condition Intervention
Renal Cell Carcinoma
Other: 89Zr-Bevacizumab PET-scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study

Resource links provided by NLM:

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Treatment with sunitinib.
Other: 89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks of treatment.
Group B
Treatment with bevacizumab and interferon
Other: 89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients locally advanced irresectable or metastatic renal cell cancer.

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
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Please refer to this study by its identifier: NCT00831857

University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Sjoukje F. Oosting, MD University Medical Center Groningen
  More Information

No publications provided

Responsible Party: S.F. Oosting-Lenstra, MD, University Medical Center Groningen Identifier: NCT00831857     History of Changes
Other Study ID Numbers: Renimage Protocol
Study First Received: January 28, 2009
Last Updated: October 1, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2015