VEGF Imaging in Renal Cell Carcinoma (Renimage)

May 3, 2024 updated by: University Medical Center Groningen

89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients locally advanced irresectable or metastatic renal cell cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after 2 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Sjoukje F. Oosting, MD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimated)

January 29, 2009

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renimage Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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