Clinical Evaluation of an Integrated PET/MRI System (PET/MR_ZURICH)

January 4, 2019 updated by: GE Healthcare
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Universitätsspital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Subject must have a clinical indication for a PET/CT exam
  2. Subject must be at least eighteen (18) years of age; and
  3. Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging; and
  4. Subject must be able to hear and understand instructions without assistive devices; and
  5. Subject must provide written informed consent; and
  6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
  7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
  8. Subject must be able to participate in a PET/MR imaging session within 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.

Exclusion Criteria:

  1. Subjects who have any axial diameter larger than 55 cm; or
  2. Subjects with a weight greater than 227 kgs; or
  3. Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator; or
  4. Subjects that have implants with MR Unsafe labeling; or
  5. Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol ; or
  6. Subjects who have a contraindication to MRI according to the screening policy of the participating site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single-Arm PET/MRI
Single-group evaluation of PET/MRI for diagnostic quality of image
Device: PET/MRI system
Enrolled subject undergoes PET/MR scan
Other Names:
  • PET/MRI system inlcudes:
  • 3T MR750w Magnet
  • MR750w XRMw Gradient
  • PET/MRI Body Coil
  • Photon Detection Ring and PET Detectors
  • PET/MR Patient Table
  • PET Electronics (mounted to magnet) and Cables

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Usable PET/MRI Image Sets
Time Frame: 1 day
The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale
1 day
Number of Diagnostic Quality Images
Time Frame: 1 day
Number of images sets deemed diagnostic quality by the investigator
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

  • Study Director: Tibor Duliskovich, Medical Doctor, GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 114-2013-GES-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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