NCT02927327

Clinical Evaluation Of MP26 Features in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Imaging
• Whole Body Imaging

Interventions

Type	Name	Description
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
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)

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2016-10-07
• Last updated: 2018-12-06
• Results posted: 2018-12-06

Locations

1 site across 1 country: United States