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Comparison of 18F FDG PET/CT TO PET MRI (PET/MR US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986985
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : May 4, 2015
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Any Condition With a Clinical Indication for PET/CT Exam
Intervention Device: PET/MRI system
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm PET MRI
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single group evaluation of PET/ MR for diagnostic quality of image

PET/MRI system: Compared to PET CT

Period Title: Overall Study
Started 58
Completed 51
Not Completed 7
Reason Not Completed
Withdrawal by Subject             4
Scan not completed due to malfunction             3
Arm/Group Title Single Arm PET MRI
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single group evaluation of PET/ MR for diagnostic quality of image

PET/MRI system: Compared to PET CT

Overall Number of Baseline Participants 58
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Intent to treat
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Adult (>=18 years) Number Analyzed 58 participants
58
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants
Male 29
Female 29
1.Primary Outcome
Title PET/MR Images Clinical Usefulness
Hide Description Clinically relevant images are obtained
Time Frame 1 day
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Hide Analysis Population Description
Subjects with images successfully collected using PET/ MR
Arm/Group Title Single Arm PET MRI
Hide Arm/Group Description:

single group evaluation of PET/ MR for diagnostic quality of image

PET/MRI system: Compared to PET CT

Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: Participants
51
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm PET MRI
Hide Arm/Group Description

single group evaluation of PET/ MR for diagnostic quality of image

PET/MRI system: Compared to PET CT

All-Cause Mortality
Single Arm PET MRI
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Single Arm PET MRI
Affected / at Risk (%) # Events
Total   0/58 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm PET MRI
Affected / at Risk (%) # Events
Total   5/58 (8.62%)    
Skin and subcutaneous tissue disorders   
Localized Warming *  4/58 (6.90%)  4
Unilateral superficial skin injury of ear from head coil placement *  1/58 (1.72%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Terri Hanlon, Clinical Affairs Project Manager
Organization: GE Healthcare
Phone: 609-578-0173
EMail: terri.hanlon@GE.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01986985    
Other Study ID Numbers: 114-2013-GES-0014
First Submitted: November 6, 2013
First Posted: November 19, 2013
Results First Submitted: March 12, 2015
Results First Posted: May 4, 2015
Last Update Posted: March 7, 2016