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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:
ClinicalTrials.gov Identifier:
NCT01105364
First Posted: April 16, 2010
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 15, 2010
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