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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

Tracking Information
First Submitted Date  ICMJE November 6, 2013
First Posted Date  ICMJE November 19, 2013
Results First Submitted Date  ICMJE March 12, 2015
Results First Posted Date  ICMJE May 4, 2015
Last Update Posted Date March 7, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
PET/MR Images Clinical Usefulness [ Time Frame: 1 day ]
Clinically relevant images are obtained
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
PET/MR images of diagnostic quality [ Time Frame: 1 day ]
Investigator indicates that the images are of diagnostic quality yes/no
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of 18F FDG PET/CT TO PET MRI
Official Title  ICMJE Comparison of 18F FDG PET/CT TO PET MRI
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Any Condition With a Clinical Indication for PET/CT Exam
Intervention  ICMJE 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
Study Arms  ICMJE Single arm PET MRI
single group evaluation of PET/MRI system scan for diagnostic quality of image
Intervention: Device: PET/MRI system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
58
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
50
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986985
Other Study ID Numbers  ICMJE 114-2013-GES-0014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roee Lazebnik, MD GE Healthcare
PRS Account GE Healthcare
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP