Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
18 Years
N/A
Both
Renal Cell Cancer
Trial Information
Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Principal Investigator
C.M.L. van Herpen, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UMC St Radboud
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
CMO 2006/232
NCT ID:
NCT00509704
Start Date:
October 2008
Completion Date:
May 2010
Related Keywords:
- Renal Cell Cancer
- Sutent
- tumor necrosis
- DCE-MRI (Dynamic enhanced magnetic resonance imaging)
- Carcinoma
- Carcinoma, Renal Cell
- Necrosis
- Neovascularization, Pathologic
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