Clinical Evaluation Of MP26 Features in Adults

Brain Imaging Clinical Trial

Official title:

Clinical Evaluation Of MP26 Features in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927327
• Other study ID #: 114.03-2016-GES-0001
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 20, 2017

Study information

• Verified date: December 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Imaging
• Whole Body Imaging

Intervention

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
• 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)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summary of Safety Information	Number of safety events (AEs and SAEs).	through study completion, an average of 2 months
Primary	Diagnostic Image Quality	scored on a 5-pt Likert scale: Unacceptable; Poor; Acceptable; Good; Excellent	through study completion, an average of 2 months
Secondary	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
Secondary	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
Secondary	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