Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
NCT ID: NCT01105364
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2007-12-31
Brief Summary
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PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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antiangiogenesis therapy
stabilized sulphur hexafluoride microbubble-based contrast agent
imaging biomarker analysis
pharmacological study
computed tomography
magnetic resonance imaging
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Principal Investigators
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F. Bruyere, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Bretonneau de Tours
Locations
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Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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CDR0000669914
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCA-RECF0653-02
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2007-005627-15
Identifier Type: -
Identifier Source: secondary_id
PFIZER-INCA-CIT07-FB-CREIN
Identifier Type: -
Identifier Source: secondary_id
INCA-CIT07-FB-CREIN
Identifier Type: -
Identifier Source: org_study_id