Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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) [ Designated as safety issue: No ]
  • Arrival time within lesion [ Designated as safety issue: No ]
  • Time-to-peak [ Designated as safety issue: No ]
  • β parameter from enhancement curve [ Designated as safety issue: No ]
  • Density of microvessels at peak enhancement [ Designated as safety issue: No ]
  • Enhancement ratio between the lesion and the surrounding parenchyma at peak value [ Designated as safety issue: No ]
  • Determination of necrotic and viable volume [ Designated as safety issue: No ]
  • Tumoral response determined by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Global survey [ Designated as safety issue: No ]
  • Tolerance to antiangiogenic treatments [ Designated as safety issue: No ]
  • Objective response for non-target lesions [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01105364     History of Changes
Other Study ID Numbers: INCA-CIT07-FB-CREIN, CDR0000669914, INCA-RECF0653-02, EUDRACT-2007-005627-15, PFIZER-INCA-CIT07-FB-CREIN
Study First Received: April 15, 2010
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer
liver metastases

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Contrast Media
Angiogenesis Inhibitors
Diagnostic Uses of Chemicals
Pharmacologic Actions
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014