Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Kidney Cancer, Metastatic Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of advanced renal cancer Planning to receive antiangiogenic treatment Detection of a target hepatic metastasis that is visible, located, and sized with conventional sonography and CT scan and/or MRI PATIENT CHARACTERISTICS: No active cardiac disease No severe arterial hypertension PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antiangiogenesis therapy|nan|
|Drug: stabilized sulphur hexafluoride microbubble-based contrast agent|nan|
|Other: imaging biomarker analysis|nan|
|Other: pharmacological study|nan|
|Procedure: computed tomography|nan|
|Procedure: magnetic resonance imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion size (main diameter) |  |  | 
| Arrival time within lesion |  |  | 
| Time-to-peak |  |  | 
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Global survey |  |  | 
| Tolerance to antiangiogenic treatments |  |  | 
| Objective response for non-target lesions |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage IV renal cell cancer, liver metastases