VEGF Imaging in Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— Renimage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831857
• Other study ID #: Renimage Protocol
• Status: Completed
• Start date: January 2009
• Est. completion date: September 2011

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• 89Zr-Bevacizumab PET-scan
At baseline, after two weeks of treatment and after 6 weeks of treatment.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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