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OpenTrials
Completed

NCT Number: NCT01986985

Comparison of 18F FDG PET/CT TO PET MRI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California - San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/MRI system

Device

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 outcomes

  1. PET/MR Images Clinical Usefulness

    Time frame: 1 day

    Clinically relevant images are obtained

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Acronym: PET/MR US

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 19, 2013
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.