Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
3 other identifiers
interventional
17
1 country
1
Brief Summary
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
May 1, 2017
4 years
September 26, 2007
February 1, 2017
May 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
F-18 FDG Tumor Uptake (SUV Max)
The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism. Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG. Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.
12 weeks minus baseline
Secondary Outcomes (8)
Histopathology
1 day
Initial Comprehensive Metabolic Panel
Prior to baseline DCE MRI
Adverse Events
up to 12 months
Tumor Necrosis
12 weeks
Tumor Size by Computed Tomography (CT) Scan
12 weeks
- +3 more secondary outcomes
Study Arms (1)
F-18 FDG PET/CT and DCE MRI
EXPERIMENTALFDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
Interventions
nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
15 mCi iv
0.1 mmol/kg iv
Eligibility Criteria
You may qualify if:
- Pathologic diagnosis of renal cell cancer
- Advanced (stage IV) renal cell cancer
- Karnofsky performance status of (KPS\>70)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Comprehensive Cancer Networkcollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The utility of the MRI- and CT-scans was significantly limited by low image quality.
Results Point of Contact
- Title
- Andrew Quon, M.D. Professor Division of Nuclear Medicine
- Organization
- David Geffen School of Medicine at UCLA
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Andrew Quon
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Radiology (Nuclear Medicine
Study Record Dates
First Submitted
September 26, 2007
First Posted
September 28, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2011
Study Completion
April 1, 2012
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
De-identified (anonymized) patient data is routinely provided upon request. Protecting patient privacy and confidentiality is the utmost consideration when sharing individual patient data. In all cases of data sharing, patient data is always anonymized to protect privacy. All potential identifiers (name, hospital ID, address,etc) are removed.