Clinical Evaluation Of MP26 Features in Adults

Study Overview
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Brief Summary
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The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. The images and summary data from this study are intended for use in regulatory submission.

Detailed Description
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Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population. Secondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites. Safety Objective(s): To collect information about safety events and device issues.

Official Title
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Clinical Evaluation Of MP26 Features in Adults

Conditions
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Brain Imaging, Whole Body Imaging

Intervention / Treatment
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* Device: Zero Echo Time (ZTE) scan for head attenuation
* Device: Q.Static (Q. MRAC) for respiratory motion correction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are adults (aged 18 or older); Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required); Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection; Can hear without assistive devices and have necessary mental capacity to follow study instructions; Are willing and able to provide written informed consent; Are considered eligible for MRI and PET exams, according to site institutional safety policies. Exclusion Criteria: Were previously enrolled in the study; If female, are pregnant or of undetermined pregnancy status; Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight); Have implants or attached medical devices that could be unsafe for MRI; Have medical conditions or require urgent care that could make it unsafe to participate

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/MR ZTE MRAC<br>PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment. Zero Echo Time (ZTE) scan for head attenuation | Device: Zero Echo Time (ZTE) scan for head attenuation<br>* The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR. PET/MR ZTE MRAC<br>|
| Experimental: PET/MR Q Static (Q. MRAC)<br>Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment. PET/MR Q Static (Q. MRAC) | Device: Q.Static (Q. MRAC) for respiratory motion correction<br>* An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images. PET/MR Q Static (Q. MRAC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Image Quality | scored on a 5-pt Likert scale: Unacceptable Poor Acceptable Good Excellent | through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Diagnostic Acceptability | Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study. | through study completion, an average of 2 months | 
| Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study. | through study completion, an average of 2 months | 
| Number of Participants Reporting Yes On All Binary Performance Scale Questions | The number of participants reporting yes on a binary performance scale (Y/N) were collected. | through study completion, an average of 2 months |