VEGF Imaging in Renal Cell Carcinoma

NCT00831857 | Completed

• 1 other identifier: Renimage Protocol
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  after 2 and 6 weeks

Secondary Outcomes (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.

  3 months after treatment

Study Arms (2)

Group A

Treatment with sunitinib.

Other: 89Zr-Bevacizumab PET-scan

Group B

Treatment with bevacizumab and interferon

Other: 89Zr-Bevacizumab PET-scan

Interventions

89Zr-Bevacizumab PET-scan OTHER

At baseline, after two weeks of treatment and after 6 weeks of treatment.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients locally advanced irresectable or metastatic renal cell cancer.

You may qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Sjoukje F. Oosting, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 29, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (1)