Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

Metastatic Cancer Clinical Trial

Official title:

Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01105364
• Other study ID #: INCA-CIT07-FB-CREIN
• Secondary ID: CDR0000669914INC
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2010
• Last updated: August 9, 2013
• Start date: December 2007

Study information

• Verified date: September 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• antiangiogenesis therapy

• stabilized sulphur hexafluoride microbubble-based contrast agent

Other:
• imaging biomarker analysis

• pharmacological study

Procedure:
• computed tomography

• magnetic resonance imaging

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion size (main diameter)			No
Primary	Arrival time within lesion			No
Primary	Time-to-peak			No
Primary	ß parameter from enhancement curve			No
Primary	Density of microvessels at peak enhancement			No
Primary	Enhancement ratio between the lesion and the surrounding parenchyma at peak value			No
Primary	Determination of necrotic and viable volume			No
Primary	Tumoral response determined by RECIST criteria			No
Secondary	Time to progression			No
Secondary	Global survey			No
Secondary	Tolerance to antiangiogenic treatments			No
Secondary	Objective response for non-target lesions			No