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Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

This study has been completed.
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00537056
First received: September 26, 2007
Last updated: April 4, 2013
Last verified: April 2013
History of Changes

September 26, 2007
April 4, 2013
October 2007
October 2011   (final data collection date for primary outcome measure)
  • histopathology [ Time Frame: clinical outcome usually prior to beginning on the trial ] [ Designated as safety issue: No ]
  • degree of tumor necrosis [ Time Frame: pre and post ( 12 weeks ) sutent therapy ] [ Designated as safety issue: No ]
  • Tumor size [ Time Frame: pre and post ( 12 weeks ) sutent therapy ] [ Designated as safety issue: No ]
  • PET/CT (tumor size - FDG uptake) [ Time Frame: pre and post ( 12 weeks ) sutent therapy ] [ Designated as safety issue: No ]
  • MRI (tumor size) [ Time Frame: pre and post ( 12 weeks ) sutent therapy ] [ Designated as safety issue: No ]
  • DCE MRI (AUC - peak flow) [ Time Frame: pre and post ( 12 weeks ) sutent therapy ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00537056 on ClinicalTrials.gov Archive Site
  • initial imaging tumor size [ Time Frame: pre sutent therapy ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: noted on imaging days ] [ Designated as safety issue: Yes ]
  • initial metabolic panel measures [ Time Frame: prior to baseline MRI ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

To learn whether FDG PET/CT and DCE MRI are better predictors of response to therapy than the current standard of care (CT or MRI).
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Kidney Neoplasms
  • Carcinoma, Renal Cell
  • Kidney (Renal Cell) Cancer
  • Procedure: FDG PET CT
    nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
    Other Name: Positron emission tomography
  • Procedure: DCE MRI
    DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
    Other Name: Magnetic Resoning Imaging
  • Drug: F-18 Fluoro-deoxi-glucose
    15 mCi iv
    Other Names:
    • fluorodeoxyglucose (18F)
    • Fludeoxyglucose (18F)
    • 18F-FDG
    • FDG
  • Drug: Gadolinium-DTPA
    0.1 mmol/kg iv
    Other Names:
    • Gadopentetic acid
    • gadopentetate dimeglumine
    • Gd-DTPA
    • Berlex
  • Drug: Sunitinib
    50 mg/day po
    Other Names:
    • Sutent
    • SU11248
Experimental: F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
Interventions:
  • Procedure: FDG PET CT
  • Procedure: DCE MRI
  • Drug: F-18 Fluoro-deoxi-glucose
  • Drug: Gadolinium-DTPA
  • Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00537056
RENAL0013, 97807, RENAL0013, 8558
Yes
Stanford University
Stanford University
National Comprehensive Cancer Network
Principal Investigator: Dr Andrew Quon Stanford University
Stanford University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP