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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Any Condition With a Clinical Indication for PET/CT Exam Device: PET/MRI system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Comparison of 18F FDG PET/CT TO PET MRI
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Single arm PET MRI
single group evaluation of PET/MRI system scan for diagnostic quality of image
Device: PET/MRI system
Compared to PET CT
Other Names:
  • PET/MRI system inlcudes:
  • 3T MR750w Magnet
  • MR750w XRMw Gradient
  • PET/MRI Body Coil
  • Photon Detection Ring and PET Detectors
  • PET/MR Patient Table
  • PET Electronics (mounted to magnet) and Cables




Primary Outcome Measures :
  1. PET/MR Images Clinical Usefulness [ Time Frame: 1 day ]
    Clinically relevant images are obtained



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Subject must have a clinical indication for a PET/CT exam
  2. Subject must be at least eighteen (18) years of age
  3. 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
  4. Subject must be able to hear and understand instructions without assistive devices
  5. Subject must provide written informed consent
  6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements
  7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
  8. Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam.

Exclusion criteria

  1. Subjects who have any axial diameter larger than 55 cm
  2. Subjects with a weight greater than 499 lbs
  3. 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
  4. Subjects that have implants with MR Unsafe labeling;
  5. 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;
  6. Subjects who have a contraindication to MRI per the screening policy of the participating site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986985


Locations
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United States, California
University of California - San Francisco
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Roee Lazebnik, MD GE Healthcare
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01986985    
Other Study ID Numbers: 114-2013-GES-0014
First Posted: November 19, 2013    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: March 7, 2016
Last Verified: February 2016