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Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

Primary Purpose

Kidney Cancer, Metastatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
antiangiogenesis therapy
stabilized sulphur hexafluoride microbubble-based contrast agent
imaging biomarker analysis
pharmacological study
computed tomography
magnetic resonance imaging
Sponsored by
National Cancer Institute, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, liver metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Bretonneau de ToursRecruiting

Outcomes

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

Full Information

First Posted
April 15, 2010
Last Updated
August 9, 2013
Sponsor
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT01105364
Brief Title
Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
Official Title
Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute, France

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Metastatic Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, liver metastases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
antiangiogenesis therapy
Intervention Type
Drug
Intervention Name(s)
stabilized sulphur hexafluoride microbubble-based contrast agent
Intervention Type
Other
Intervention Name(s)
imaging biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Primary Outcome Measure Information:
Title
Lesion size (main diameter)
Title
Arrival time within lesion
Title
Time-to-peak
Title
β parameter from enhancement curve
Title
Density of microvessels at peak enhancement
Title
Enhancement ratio between the lesion and the surrounding parenchyma at peak value
Title
Determination of necrotic and viable volume
Title
Tumoral response determined by RECIST criteria
Secondary Outcome Measure Information:
Title
Time to progression
Title
Global survey
Title
Tolerance to antiangiogenic treatments
Title
Objective response for non-target lesions

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Bruyere, MD
Organizational Affiliation
Centre Hospitalier Universitaire Bretonneau de Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
33-2-4747-4776

12. IPD Sharing Statement

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Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

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