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

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

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Key information

Conditions

Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC St Radboud

Nijmegen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

Novo Nordisk A/S

Registry information

Official study title

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

Important dates

Study start: 2008
Study completion: 2010
First posted: Jul 31, 2007
Registry last updated: Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed