Clinical trial NCT01105364: Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
Official title: Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Cancer
Metastatic Cancer
Keywords: recurrent renal cell cancer
stage IV renal cell cancer
liver metastases
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-04-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Lesion size (main diameter)
measure: Arrival time within lesion
measure: Time-to-peak
measure: β parameter from enhancement curve
measure: Density of microvessels at peak enhancement
measure: Enhancement ratio between the lesion and the surrounding parenchyma at peak value
measure: Determination of necrotic and viable volume
measure: Tumoral response determined by RECIST criteria
Secondary outcomes:
measure: Time to progression
measure: Global survey
measure: Tolerance to antiangiogenic treatments
measure: Objective response for non-target lesions
Other outcomes:
Locations:
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
Study officials:
affiliation: Centre Hospitalier Universitaire Bretonneau de Tours
name: F. Bruyere, MD
role: PRINCIPAL_INVESTIGATOR
References: