Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
|ClinicalTrials.gov Identifier: NCT01105364|
Recruitment Status : Unknown
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 16, 2010
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment|
|Kidney Cancer Metastatic 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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||March 2012|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105364
|Centre Hospitalier Universitaire Bretonneau de Tours||Recruiting|
|Tours, France, 37044|
|Contact: Contact Person 33-2-4747-4776|
|Principal Investigator:||F. Bruyere, MD||Centre Hospitalier Universitaire Bretonneau de Tours|