Trial Information

Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography

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.