Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
|
N/A |
Detailed Description
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
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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.
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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.
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To determine the tolerance to antiangiogenic treatments in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Time to progression []
- Global survey []
- Tolerance to antiangiogenic treatments []
- Objective response for non-target lesions []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of advanced renal cancer
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Planning to receive antiangiogenic treatment
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Detection of a target hepatic metastasis that is visible, located, and sized with conventional sonography and CT scan and/or MRI
PATIENT CHARACTERISTICS:
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No active cardiac disease
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No severe arterial hypertension
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire Bretonneau de Tours | Tours | France | 37044 |
Sponsors and Collaborators
- National Cancer Institute, France
Investigators
- Principal Investigator: F. Bruyere, MD, Centre Hospitalier Universitaire Bretonneau de Tours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INCA-CIT07-FB-CREIN
- CDR0000669914
- INCA-RECF0653-02
- EUDRACT-2007-005627-15
- PFIZER-INCA-CIT07-FB-CREIN