Clinical Evaluation of an Integrated PET/MRI System (PET/MR_ZURICH)

General Electric (GE)

Status: Completed

Conditions: Subjects With Clinical Indication for PET/CT

Treatments: Device: PET/MRI system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02071706

114-2013-GES-0010

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Single-Arm PET/MRI

Other group

Description:

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

Treatment:

Device: PET/MRI system