Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
Recruitment status was: Recruiting
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.
Drug: antiangiogenesis therapy
Drug: stabilized sulphur hexafluoride microbubble-based contrast agent
Other: imaging biomarker analysis
Other: pharmacological study
Procedure: computed tomography
Procedure: magnetic resonance imaging
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography|
- Lesion size (main diameter)
- Arrival time within lesion
- β parameter from enhancement curve
- Density of microvessels at peak enhancement
- Enhancement ratio between the lesion and the surrounding parenchyma at peak value
- Determination of necrotic and viable volume
- Tumoral response determined by RECIST criteria
- Time to progression
- Global survey
- Tolerance to antiangiogenic treatments
- Objective response for non-target lesions
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105364
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Principal Investigator:||F. Bruyere, MD||Centre Hospitalier Universitaire Bretonneau de Tours|