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VEGF Imaging in Renal Cell Carcinoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00831857
Acronym
Renimage
Enrollment
26
Registered
2009-01-29
Start date
2009-01-31
Completion date
2011-09-30
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

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.

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.

Interventions

OTHER89Zr-Bevacizumab PET-scan

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

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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.after 2 and 6 weeks

Secondary

MeasureTime 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.3 months after treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026