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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: |
NCT00537056 |
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Date of registration:
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26/09/2007 |
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Primary sponsor: |
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Public title:
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Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
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Scientific title:
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Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00537056 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, 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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Dr Andrew Quon |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:- Measurable disease by RECIST criteria
- Pathologic diagnosis of renal cell cancer
- Advanced (stage IV) renal cell cancer
- Karnofsky performance status of (KPS>70)
- Consent to participate in the clinical trial
Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
- Pregnant women.
- Healthy volunteers.
- Patients participating in other research protocols will be excluded from this study.
- Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications
for MRI.
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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Carcinoma, Renal Cell
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Kidney (Renal Cell) Cancer
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Kidney Neoplasms
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Intervention(s)
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Drug: F-18 Fluoro-deoxi-glucose
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Drug: Gadolinium-DTPA
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Drug: Sunitinib
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Procedure: DCE MRI
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Procedure: FDG PET CT
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Primary Outcome(s)
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DCE MRI (AUC - peak flow)
[Time Frame: pre and post ( 12 weeks ) sutent therapy]
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degree of tumor necrosis
[Time Frame: pre and post ( 12 weeks ) sutent therapy]
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histopathology
[Time Frame: clinical outcome usually prior to beginning on the trial]
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MRI (tumor size)
[Time Frame: pre and post ( 12 weeks ) sutent therapy]
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PET/CT (tumor size - FDG uptake)
[Time Frame: pre and post ( 12 weeks ) sutent therapy]
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Tumor size
[Time Frame: pre and post ( 12 weeks ) sutent therapy]
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Secondary Outcome(s)
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adverse events
[Time Frame: noted on imaging days]
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initial imaging tumor size
[Time Frame: pre sutent therapy]
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initial metabolic panel measures
[Time Frame: prior to baseline MRI]
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Secondary ID(s)
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97807
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RENAL0013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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