Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

August 9, 2013 updated by: National Cancer Institute, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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