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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

July 11, 2008

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00537056 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

initial imaging tumor size
initial metabolic panel measures
adverse events

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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).

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Kidney Neoplasms
Carcinoma, Renal Cell

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537056

Responsible Party

Secondary IDs ^††

97807, NCT00537056, RENAL0013

Study Sponsor ^†

Stanford University

Collaborators ^††

NCCN - National Comprehensive Cancer Network

Investigators ^†

Principal Investigator:

Dr Andrew Quon

Stanford University

Information Provided By

Stanford University

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.