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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00509704

Collaborator

Novo Nordisk A/S (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Cancer

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Study Completion Date :

May 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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