Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

Study Description

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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
Kidney Cancer; Metastatic Cancer	Drug: antiangiogenesis therapy; Drug: stabilized sulphur hexafluoride microbubble-based contrast agent; Other: imaging biomarker analysis; Other: pharmacological study; Procedure: computed tomography; Procedure: magnetic resonance imaging	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Primary Purpose:	Diagnostic
Official Title:	Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography
Study Start Date :	December 2007
Estimated Primary Completion Date :	March 2012

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Lesion size (main diameter)
2. Arrival time within lesion
3. Time-to-peak
4. β parameter from enhancement curve
5. Density of microvessels at peak enhancement
6. Enhancement ratio between the lesion and the surrounding parenchyma at peak value
7. Determination of necrotic and viable volume
8. Tumoral response determined by RECIST criteria

Secondary Outcome Measures :

1. Time to progression
2. Global survey
3. Tolerance to antiangiogenic treatments
4. Objective response for non-target lesions

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

France
Centre Hospitalier Universitaire Bretonneau de Tours	Recruiting
Tours, France, 37044
Contact: Contact Person 33-2-4747-4776

Sponsors and Collaborators

National Cancer Institute, France

Investigators

Principal Investigator:	F. Bruyere, MD	Centre Hospitalier Universitaire Bretonneau de Tours

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT01105364 History of Changes
Other Study ID Numbers:	INCA-CIT07-FB-CREIN; CDR0000669914 ( Registry Identifier: PDQ (Physician Data Query) ); INCA-RECF0653-02; EUDRACT-2007-005627-15; PFIZER-INCA-CIT07-FB-CREIN
First Posted:	April 16, 2010
Last Update Posted:	August 12, 2013
Last Verified:	September 2011

Keywords provided by National Cancer Institute (NCI):

recurrent renal cell cancer; stage IV renal cell cancer; liver metastases

Additional relevant MeSH terms:

Neoplasm Metastasis; Kidney Neoplasms; Carcinoma, Renal Cell; Neoplastic Processes; Neoplasms; Pathologic Processes; Urologic Neoplasms; Urogenital Neoplasms	Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type