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

NCT01992354 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-03-19

Study results available
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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.

Conditions

  • Indication for a PET CT Exam

Interventions

DEVICE

PET MR Device

GE PET/MRI system

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Robert Prost, PhD · Froedtert Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-01-31
Completion
2015-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992354 on ClinicalTrials.gov