Clinical Evaluation Of MP26 Features in Adults

Not Applicable

Completed

Interventions: Device: Q.Static (Q. MRAC) for respiratory motion correction
Device: Zero Echo Time (ZTE) scan for head attenuation

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PET/MR Q Static (Q. MRAC)	Q.Static (Q. MRAC) for respiratory motion correction	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)
PET/MR ZTE MRAC	Zero Echo Time (ZTE) scan for head attenuation	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

Primary Outcome Measures

Name	Time	Method
Diagnostic Image Quality	through study completion, an average of 2 months	scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent

Secondary Outcome Measures

Name	Time	Method
Determination of Diagnostic Acceptability	through study completion, an average of 2 months	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.
Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score	through study completion, an average of 2 months	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.
Number of Participants Reporting "Yes" On All Binary Performance Scale Questions	through study completion, an average of 2 months	The number of participants reporting "yes" on a binary performance scale (Y/N) were collected.