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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000669914 | Registry Identifier | PDQ (Physician Data Query) | |
| INCA-RECF0653-02 | |||
| EUDRACT-2007-005627-15 | |||
| PFIZER-INCA-CIT07-FB-CREIN |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiangiogenesis therapy | Drug | |||
| stabilized sulphur hexafluoride microbubble-based contrast agent | Drug | |||
| imaging biomarker analysis | Other | |||
| pharmacological study | Other | |||
| computed tomography | Procedure | |||
| magnetic resonance imaging | Procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | ||
| Global survey | ||
| Tolerance to antiangiogenic treatments |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| F. Bruyere, MD | Centre Hospitalier Universitaire Bretonneau de Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting | Tours | 37044 | France |
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| Objective response for non-target lesions |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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