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Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components

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: NCT01992354
Recruitment Status : Terminated (Low enrollment)
First Posted : November 25, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 19, 2019
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);   Primary Purpose: Other
Condition Indication for a PET CT Exam
Intervention Device: PET MR Device
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PET/MR System
Hide Arm/Group Description

Evaluation of Positron Emission Tomography/Magnetic Resonance (PET/MR) device for image assessment and device performance

PET MR Device: General Electric (GE) PET/MRI system
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description

Evaluation of PET MR device for image assessment and device performance

PET MR Device: GE PET/MRI system
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years 0
Between 18 and 65 years 4
>=65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female 0
Male 4
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title PET/MR Scan Obtained
Hide Description One PET/MR scan per subject should be obtained. The scan images are evaluated by a subject matter expert for adequate diagnostic quality.
Time Frame One (1) day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PET/MR System
Hide Arm/Group Description:

Evaluation of PET MR device for image assessment and device performance

PET MR Device: GE PET/MRI system
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: scans completed
Scans supporting Aim 1 5
Scans supporting Aim 2 0
Scans supporting Aim 3 0
2.Secondary Outcome
Title Device Complaints
Hide Description Number of device complaints reported during a scan
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PET/MR System
Hide Arm/Group Description:

Evaluation of Positron Emission Tomography/Magnetic Resonance (PET/MR) device for image assessment and device performance

PET MR Device: General Electric (GE) PET/MRI system
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Device complatints reported
0
Time Frame One (1) day
Adverse Event Reporting Description One (1) day, during diagnostic procedure
 
Arm/Group Title PET/MR System
Hide Arm/Group Description

Evaluation of PET MR device for image assessment and device performance

PET MR Device: GE PET/MRI system
All-Cause Mortality
PET/MR System
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Serious Adverse Events
PET/MR System
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PET/MR System
Affected / at Risk (%)
Total   0/4 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: John Strohmeyer
Organization: GE Healthcare
Phone: +1 609 865 7423
EMail: john.strohmeyer@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01992354    
Other Study ID Numbers: 114-2013-GES-0012
First Submitted: November 6, 2013
First Posted: November 25, 2013
Results First Submitted: January 15, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 19, 2019