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NCT00509704 Clinical Trial

Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma

Renal Cell Cancer Clinical Trial

Official title:
Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00509704
Other study ID # CMO 2006/232
Secondary ID
Status Completed
Phase N/A
First received July 30, 2007
Last updated November 8, 2010
Start date October 2008
Est. completion date May 2010

Study information
Verified date October 2010
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.

Description:

Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date May 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned

- histologically verified stage IV renal cell carcinoma of clear cell type

- measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs

- Karnofsky score > 70%

- age > 18 year.

- written informed consent

Exclusion Criteria:

- contra-indications for MRI

- contra-indications for treatment with Sunitinib

- previous systemic treatment within the last 30 days

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands UMC St Radboud Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

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