Clinical Evaluation of an Integrated PET/MRI System

GE Healthcare1 site in 1 country62 target enrollmentJanuary 2014

ConditionsSubjects With Clinical Indication for PET/CT

Overview

Phase: N/A
Intervention: Not specified
Conditions: Subjects With Clinical Indication for PET/CT
Sponsor: GE Healthcare
Enrollment: 62
Locations: 1
Primary Endpoint: Number Usable PET/MRI Image Sets
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

August 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must have a clinical indication for a PET/CT exam
•Subject must be at least eighteen (18) years of age; and
•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; and
•Subject must be able to hear and understand instructions without assistive devices; and
•Subject must provide written informed consent; and
•Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
•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 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.

Exclusion Criteria

•Subjects who have any axial diameter larger than 55 cm; or
•Subjects with a weight greater than 227 kgs; or
•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; or
•Subjects that have implants with MR Unsafe labeling; or
•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 ; or
•Subjects who have a contraindication to MRI according to the screening policy of the participating site