Clinical Evaluation of an Integrated PET/MRI System

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

Official Title
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Clinical Evaluation of an Integrated PET/MRI System

Conditions
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Subjects With Clinical Indication for PET/CT

Intervention / Treatment
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* Device: PET/MRI system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have a clinical indication for a PET/CT exam Subject must be at least eighteen (18) years of age; and 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 Subject must be able to hear and understand instructions without assistive devices; and Subject must provide written informed consent; and Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and 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: Subjects who have any axial diameter larger than 55 cm; or Subjects with a weight greater than 227 kgs; or 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 Subjects that have implants with MR Unsafe labeling; or 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 Subjects who have a contraindication to MRI according to the screening policy of the participating site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Arm PET/MRI<br>Single-group evaluation of PET/MRI for diagnostic quality of image | Device: PET/MRI system<br>* Enrolled subject undergoes PET/MR scan<br>* Other names: PET Electronics (mounted to magnet) and Cables;|

What is the study measuring?
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Primary Outcome Measures

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