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Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.


Clinical Trial Description

OBJECTIVES:

Primary

- To determine if contrast-enhanced ultrasonography (CEUS) study of target metastasis from renal cancer leads to early assessment of pharmacodynamic effects of antiangiogenic treatment in patients with advanced renal cancer.

Secondary

- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the time to progression.

- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the global survey.

- To determine the tolerance to antiangiogenic treatments in these patients.

- To determine the relationship between functional changes of microvascularization and the target lesion and the objective response for the other lesions (RECIST criteria) in cases of other metastasis other than the target lesion.

OUTLINE: Patients undergo contrast-enhanced ultrasonography (CEUS) before and after stabilized sulphur hexafluoride microbubble-based contrast agent injection. CEUS is done within 8 days prior to, 30 days after the first administration, and after 3 months of receiving antiangiogenesis treatment (e.g., sunitinib malate, sorafenib tosylate, or bevacizumab). Patients also undergo computed tomography and magnetic resonance imaging to evaluate tumoral targets.

After completion of study treatment, patients are followed up for 2 years. ;


Study Design

Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01105364
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase N/A
Start date December 2007

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