NCT01992354

Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components

Development of an Integrated PET/MR System, Accessories and Components

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PET/MR device components and accessories are under development in order to optimize, validate and improve the design including improving the quality of images. The purpose of this study is: * Aim 1: Perform iterative evaluations of the device (including features and components) to optimize device performance and assess feasibility of new features; * Aim 2: Perform activities in support of design validation as needed for regulatory submission; * Aim 3: Evaluate device complaints and analyze potential causes.

Detailed description

This is a non-randomized, non-statistically powered, single-site, prospective study designed to gather imaging data for design optimization, regulatory submission and future product development of an investigational hybrid PET/MRI scanner. Subjects will undergo a clinically indicated PET/CT exam subsequent to tracer administration. Once clinical imaging is complete, subjects will be transported to the PET/MR scanner at the General Electric (GE) Facility for additional imaging. No additional pharmaceuticals or ionizing radiation will be utilized as part of this study.

Conditions

• Indication for a PET CT Exam

Interventions

Type	Name	Description
DEVICE	PET MR Device	GE PET/MRI system

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-11-25
• Last updated: 2019-03-19
• Results posted: 2019-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study