Comparison of 18F FDG PET/CT TO PET MRI

NCT ID: NCT01986985

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Any Condition With a Clinical Indication for PET/CT Exam

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Single arm PET MRI

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

Group Type: OTHER

PET/MRI system

Intervention Type: DEVICE

Compared to PET CT

Interventions

PET/MRI system

Compared to PET CT

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

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.

• 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

Roee Lazebnik, MD

Role: STUDY_DIRECTOR

GE Healthcare

Locations

University of California - San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

114-2013-GES-0014

Identifier Type: -

Identifier Source: org_study_id