Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT01105364

First received: April 15, 2010

Last updated: August 9, 2013

Last verified: September 2011

History of Changes

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	Primary Purpose: Diagnostic
Official Title:	Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography

Resource links provided by NLM:

MedlinePlus related topics: Kidney Cancer Ultrasound

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Time to progression
Global survey
Tolerance to antiangiogenic treatments
Objective response for non-target lesions


Estimated Enrollment:	50
Study Start Date:	December 2007
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105364

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


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
Study First Received:	April 15, 2010
Last Updated:	August 9, 2013

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

ClinicalTrials.gov processed this record on June 28, 2017

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