Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
Conditions
Kidney Cancer - Metastatic Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms - Neoplasm Metastasis
Conditions: Keywords
recurrent renal cell cancer, stage IV renal cell cancer, liver metastases
Study Type
Interventional
Study Phase
N/A
Study Design
Primary Purpose: Diagnostic
Intervention
Name: antiangiogenesis therapy Type: Drug
Name: stabilized sulphur hexafluoride microbubble-based contrast agent Type: Drug
Name: imaging biomarker analysis Type: Other
Name: pharmacological study Type: Other
Name: computed tomography Type: Procedure
Name: magnetic resonance imaging Type: Procedure
Overall Status
Recruiting
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.
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

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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
Location
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France
Status: Recruiting
Contact: Contact Person - 33-2-4747-4776
Start Date
December 2007
Sponsors
National Cancer Institute, France
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page