Clinical Evaluation of an Integrated PET/MRI System

Clinical Evaluation of an Integrated PET/MRI System

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

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