- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01986985
Comparison of 18F FDG PET/CT TO PET MRI (PET/MR US)
February 9, 2016 updated by: GE Healthcare
The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing.
Clinical data is required in order to test the MR attenuation correction of PET data.
These aims can only be accomplished through a clinical study.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- University of California - San Francisco
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Subject must have a clinical indication for a PET/CT exam
- Subject must be at least eighteen (18) years of age
- Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging
- Subject must be able to hear and understand instructions without assistive devices
- Subject must provide written informed consent
- Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements
- Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
- Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam.
Exclusion criteria
- Subjects who have any axial diameter larger than 55 cm
- Subjects with a weight greater than 499 lbs
- Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator
- Subjects that have implants with MR Unsafe labeling;
- Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol;
- Subjects who have a contraindication to MRI per the screening policy of the participating site.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm PET MRI
single group evaluation of PET/MRI system scan for diagnostic quality of image
|
Compared to PET CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PET/MR Images Clinical Usefulness
Time Frame: 1 day
|
Clinically relevant images are obtained
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Roee Lazebnik, MD, GE Healthcare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
November 6, 2013
First Submitted That Met QC Criteria
November 18, 2013
First Posted (Estimate)
November 19, 2013
Study Record Updates
Last Update Posted (Estimate)
March 7, 2016
Last Update Submitted That Met QC Criteria
February 9, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 114-2013-GES-0014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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