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

This study is currently recruiting participants.

Verified by Stanford University, July 2009

First Received: September 26, 2007 Last Updated: July 27, 2009 History of Changes

Sponsors and Collaborators:	Stanford University NCCN - National Comprehensive Cancer Network
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00537056

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	Drug: Sunitinib Procedure: FDG PET Procedure: PET/CT

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Fluorodeoxyglucose F18 Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

histopathology
tumor size
degree of tumor necrosis
PET/CT (tumor size - FDG uptake)
MRI (tumor size)
DCE MRI (AUC - peak flow)

Secondary Outcome Measures:

initial imaging tumor size
initial metabolic panel measures
adverse events

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Peralta Dana

(650) 725-1730

pdawn07@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Peralta Dana 650-725-1730 pdawn07@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Dr Andrew Quon
Sub-Investigator: Robert J Herfkens
Sub-Investigator: Dr Terry Desser

Sponsors and Collaborators

Stanford University

NCCN - National Comprehensive Cancer Network

Investigators

Principal Investigator:

Dr Andrew Quon

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Dr Andrew Quon, Principal Investigator )
Study ID Numbers:	RENAL0013, 97807, NCT00537056, RENAL0013
Study First Received:	September 26, 2007
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00537056 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Carcinoma
Renal Cancer

Urologic Diseases
Kidney Neoplasms
Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009