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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
  Purpose

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).


Condition Intervention
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney (Renal Cell) Cancer
 Procedure: FDG PET CT
Procedure: DCE MRI
Drug: F-18 Fluoro-deoxi-glucose
Drug: Gadolinium-DTPA
Drug: Sunitinib

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: October 2007
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537056

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Comprehensive Cancer Network
Investigators
Principal Investigator: Dr Andrew Quon Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00537056     History of Changes
Other Study ID Numbers: RENAL0013, 97807, RENAL0013, 8558
Study First Received: September 26, 2007
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Pentetic Acid
Sunitinib
 Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013