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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00509704

Enrollment

Registered

2007-07-31

Start date

2008-10-31

Completion date

2010-05-31

Last updated

2010-11-09

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

Conditions

Renal Cell Cancer

Keywords

Sutent, tumor necrosis, DCE-MRI (Dynamic enhanced magnetic resonance imaging)

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Exclusion criteria

* contra-indications for MRI * contra-indications for treatment with Sunitinib * previous systemic treatment within the last 30 days

Countries

Netherlands

Outcome results