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VEGF Imaging in Renal Cell Carcinoma (Renimage)

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ClinicalTrials.gov Identifier: NCT00831857
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
S.F. Oosting-Lenstra, 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.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Other: 89Zr-Bevacizumab PET-scan

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 Type : Observational
Actual Enrollment : 26 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831857


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

Responsible Party: S.F. Oosting-Lenstra, MD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00831857     History of Changes
Other Study ID Numbers: Renimage Protocol
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015

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
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents