Clinical Evaluation Of MP26 Features in Adults

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.

Study Overview

• Status: Completed
• Conditions: Brain Imaging; Whole Body Imaging
• Intervention / Treatment: Device: Zero Echo Time (ZTE) scan for head attenuation; Device: Q.Static (Q. MRAC) for respiratory motion correction

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are adults (aged 18 or older);
2. 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);
3. Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
4. Can hear without assistive devices and have necessary mental capacity to follow study instructions;
5. Are willing and able to provide written informed consent;
6. Are considered eligible for MRI and PET exams, according to site institutional safety policies.

Exclusion Criteria:

1. Were previously enrolled in the study;
2. If female, are pregnant or of undetermined pregnancy status;
3. Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
4. Have implants or attached medical devices that could be unsafe for MRI;
5. Have medical conditions or require urgent care that could make it unsafe to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/MR ZTE MRAC; 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; 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
Experimental: PET/MR Q Static (Q. MRAC); 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; 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Safety Information	Number of safety events (AEs and SAEs).	through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Study Director: Tibor Duliskovich, M.D., GE Healthcare, Medical Monitor

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 7, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 114.03-2016-GES-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No