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

NCT ID: NCT00509704

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Renal Cell Cancer

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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University Medical Centre Nijmegen, st Radboud

Principal Investigators

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C.M.L. van Herpen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Locations

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UMC St Radboud

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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CMO 2006/232

Identifier Type: -

Identifier Source: org_study_id