Clinical Evaluation of an Integrated PET/MRI System

NCT ID: NCT02071706

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-08-31

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.

Conditions

Subjects With Clinical Indication for PET/CT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single-Arm PET/MRI

Single-group evaluation of PET/MRI for diagnostic quality of image

Group Type: OTHER

PET/MRI system

Intervention Type: DEVICE

Enrolled subject undergoes PET/MR scan

Interventions

PET/MRI system

Enrolled subject undergoes PET/MR scan

Intervention Type: DEVICE

Other Intervention 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

Eligibility 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; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibor Duliskovich, Medical Doctor

Role: STUDY_DIRECTOR

GE Healthcare

Locations

UniversitätsSpital Zürich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

114-2013-GES-0010

Identifier Type: -

Identifier Source: org_study_id