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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Carcinoma, Renal Cell
Carcinoma
Kidney Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Fluorodeoxyglucose F18
Sunitinib
Gadolinium DTPA
Gadobenic acid
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Contrast Media

ClinicalTrials.gov processed this record on September 22, 2014