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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00953446 |
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Date of registration:
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05/08/2009 |
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Primary sponsor: |
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Public title:
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Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma
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Scientific title:
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Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of the Response to Therapy With the Combination of Sunitinib and AMG386 in Metastatic Renal Cell Carcinoma |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00953446 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Ivan Pedrosa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beth Israel Deaconess Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age greater than 18 years
- Patients diagnosed with metastatic renal cell carcinoma and who will initiate therapy
with the combination of sunitinib and AMG386 as either their first anti-angiogenic
therapy or after failure of prior cytokine therapy
- Enrolled on protocol 06-105, "Collection of specimens and clinical data from patients
with renal cell carcinoma treated with targeted therapies"
- Found to have tumors that are >/=2.5 cm as determined by CT imaging
- Candidate lesions for ASL MRI should be >/= 2.5cm. Order of preference of lesion
location will be as follows: abdominal lesions, bone lesions and chest lesions
Exclusion Criteria:
- Subjects will be excluded from the study if they have a contraindication to MRI which
may include the following: Pacemaker, MRI incompatible metal implant, recently
implanted vascular clip, history of claustrophobia, metal fragment within the eye
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Cell Carcinoma
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Intervention(s)
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Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging
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Primary Outcome(s)
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To compare above results to those observed in a comparable patient population receiving sunitinib alone.
[Time Frame: 2 years]
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To evaluate the association between changes in tumor blood flow on ASL over the course of therapy and at the time of disease progression and resistance to therapy.
[Time Frame: 2 years]
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To explore the association of baseline blood flow in renal cell carcinoma(RCC) measured by ASL MRI and tumor response to treatment with the combination of sunitinib and AMG386
[Time Frame: 2 years]
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To explore the association of changes in tumor blood flow that occur early in the course of therapy compared to baseline and response of RCC to treatment with the combination of sunitinib and AMG386
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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