Clinical Evaluation of an Integrated PET/MRI System

Not Applicable

Completed

• Conditions: Subjects With Clinical Indication for PET/CT
• Interventions: Device: PET/MRI system

• Registration Number: NCT02071706
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-23
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-26
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-07-20
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-04
• Last Update Submitted: 2019-01-04
• Results First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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; and
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; and
4. Subject must be able to hear and understand instructions without assistive devices; and
5. Subject must provide written informed consent; and
6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
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 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm PET/MRI	PET/MRI system	Single-group evaluation of PET/MRI for diagnostic quality of image

Primary Outcome Measures

Name	Time	Method
Number Usable PET/MRI Image Sets	1 day	The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale
Number of Diagnostic Quality Images	1 day	Number of images sets deemed diagnostic quality by the investigator

Trial Locations

Locations (1)

UniversitätsSpital Zürich; 🇨🇭 Zurich, Switzerland