Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
This study is currently recruiting participants.
Verified September 2011 by National Cancer Institute (NCI)
Sponsor:
National Cancer Institute, France
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01105364
First received: April 15, 2010
Last updated: September 28, 2011
Last verified: September 2011
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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) |
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
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: | CDR0000669914, INCA-CIT07-FB-CREIN, INCA-RECF0653-02, EUDRACT-2007-005627-15, PFIZER-INCA-CIT07-FB-CREIN |
| Study First Received: | April 15, 2010 |
| Last Updated: | September 28, 2011 |
| 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 Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013