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Trial record 55 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT00537056
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Andrew Quon, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Kidney Neoplasms
Carcinoma, Renal Cell
Kidney (Renal Cell) Cancer
Interventions Procedure: FDG PET CT
Procedure: DCE MRI
Drug: F-18 Fluoro-deoxi-glucose
Drug: Gadolinium-DTPA
Drug: Sunitinib
Enrollment 17
Recruitment Details Seventeen previously untreated adult patients with advanced stage IV renal cell carcinoma (RCC) were prospectively recruited to Stanford Hospital and Clinics for a baseline PET/CT scan followed by a 12-month follow-up PET/CT scan post sunitinib therapy.
Pre-assignment Details  
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description 15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
Period Title: Baseline PET/CT
Started 17
Completed 17
Not Completed 0
Period Title: Interim PET/CT
Started 17
Completed 12
Not Completed 5
Reason Not Completed
scheduling conflicts and/or exposure             5
Period Title: 12-month Follow-up
Started 17
Completed 17
Not Completed 0
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description

FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po

FDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body

DCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).

F-18 Fluoro-deoxi-glucose: 15 mCi iv

Gadolinium-DTPA: 0.1 mmol/kg iv

Sunitinib: 50 mg/day po

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
5
  29.4%
Male
12
  70.6%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
[1]
Measure Description: Stanford Hospital and Clinics
1.Primary Outcome
Title F-18 FDG Tumor Uptake (SUV Max)
Hide Description

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.

Time Frame 12 weeks minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All patients underwent baseline F-18 FDG PET scan. Mean SUVmax at baseline is reported (row 1). 6 participants achieved progression-free survival after post-sunitinib therapy, and their SUVmax values were averaged (row 2). 11 participants had progression or recurrence/relapse of disease and their SUVmax values were averaged (row 3).
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: SUVmax
Baseline SUVmax Number Analyzed 17 participants
9.8  (5.7)
Mean SUVmax, progression-free survival Number Analyzed 6 participants
-18.9  (15.1)
SUVmax, progression/relapse Number Analyzed 11 participants
34.0  (39.7)
2.Secondary Outcome
Title Histopathology
Hide Description Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with renal cell carcinoma
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
3.Secondary Outcome
Title Initial Comprehensive Metabolic Panel
Hide Description A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.
Time Frame Prior to baseline DCE MRI
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
4.Secondary Outcome
Title Adverse Events
Hide Description Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: adverse events
0
5.Secondary Outcome
Title Tumor Necrosis
Hide Description The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
The DCE MRI image was obtained but image quality was poor and the degree of tumor necrosis could not be determined.
6.Secondary Outcome
Title Tumor Size by Computed Tomography (CT) Scan
Hide Description Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
The CT scan performed immediately prior to the PET scan was of poor (non-diagnostic) quality and did not provide usable size measurement data.
7.Secondary Outcome
Title Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan
Hide Description Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
The DCE MRI image was obtained but image quality was poor and provided no useful data from which to determine tumor size.
8.Secondary Outcome
Title DCE MRI AUC Peak Flow
Hide Description Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
The DCE MRI image was obtained but image quality was poor and provided no useful data to determine AUC.
9.Secondary Outcome
Title Initial Tumor Size
Hide Description Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.
Time Frame pre-sunitinib therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description:
15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
The CT scan performed immediately prior to the PET scan was of poor image quality (non-diagnostic) and did not provide usable measurement data.
Time Frame up to 12 months
Adverse Event Reporting Description No adverse events were noted, and none are reported.
 
Arm/Group Title F-18 FDG PET/CT and DCE MRI
Hide Arm/Group Description 15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
All-Cause Mortality
F-18 FDG PET/CT and DCE MRI
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
F-18 FDG PET/CT and DCE MRI
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
F-18 FDG PET/CT and DCE MRI
Affected / at Risk (%)
Total   0/17 (0.00%) 
The utility of the MRI- and CT-scans was significantly limited by low image quality.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Andrew Quon, M.D. Professor Division of Nuclear Medicine
Organization: David Geffen School of Medicine at UCLA
Phone: 310-983-1419
Responsible Party: Andrew Quon, Stanford University
ClinicalTrials.gov Identifier: NCT00537056     History of Changes
Other Study ID Numbers: IRB-08558
97807 ( Other Identifier: Stanford University Alternate IRB Approval Number )
RENAL0013 ( Other Identifier: OnCore )
First Submitted: September 26, 2007
First Posted: September 28, 2007
Results First Submitted: February 1, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017