Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

National Cancer Institute, France

Status: Unknown

Conditions: Metastatic Cancer; Kidney Cancer

Treatments: Drug: stabilized sulphur hexafluoride microbubble-based contrast agent; Other: imaging biomarker analysis; Procedure: magnetic resonance imaging; Other: pharmacological study; Procedure: computed tomography; Drug: antiangiogenesis therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01105364

INCA-RECF0653-02

CDR0000669914 (Registry Identifier)

INCA-CIT07-FB-CREIN

PFIZER-INCA-CIT07-FB-CREIN

EUDRACT-2007-005627-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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