VEGF Imaging in Renal Cell Carcinoma (Renimage)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

S.F. Oosting-Lenstra, University Medical Centre Groningen

ClinicalTrials.gov Identifier:

NCT00831857

First received: January 28, 2009

Last updated: September 27, 2011

Last verified: September 2011

History of Changes

Purpose

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:

MedlinePlus related topics: Nuclear Scans

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by University Medical Centre 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 ]

Estimated 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.

Eligibility

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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831857

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

University Medical Centre Groningen

Investigators

Principal Investigator:

Sjoukje F. Oosting, MD

University Medical Centre Groningen

More Information

No publications provided

Responsible Party:	S.F. Oosting-Lenstra, MD, University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00831857 History of Changes
Other Study ID Numbers:	Renimage Protocol
Study First Received:	January 28, 2009
Last Updated:	September 27, 2011
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases

Urologic Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

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