Comparison of 18F FDG PET/CT TO PET MRI (PET/MR US)

General Electric (GE)

Status: Completed

Conditions: Any Condition With a Clinical Indication for PET/CT Exam

Treatments: Device: PET/MRI system

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986985

114-2013-GES-0014

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

58 participants in 1 patient group

Single arm PET MRI

Other group

Description:

single group evaluation of PET/MRI system scan for diagnostic quality of image

Treatment:

Device: PET/MRI system