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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992354
Recruitment Status : Terminated (Low enrollment)
First Posted : November 25, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Indication for a PET CT Exam Device: PET MR Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of an Integrated PET/MR System, Accessories and Components
Study Start Date : November 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Single Arm
Evaluation of PET MR device for image assessment and device performance
Device: PET MR Device
GE PET/MRI system




Primary Outcome Measures :
  1. PET/MR Scan Obtained [ Time Frame: One (1) day ]
    One PET/MR scan per subject should be obtained. The scan images are evaluated by a subject matter expert for adequate diagnostic quality.


Secondary Outcome Measures :
  1. Device Complaints [ Time Frame: One day ]
    Number of device complaints reported during a scan



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have a clinical indication for a PET/CT exam
  • Subject must be at least eighteen (18) years of age; and
  • Subject must be able to hear and understand instructions without assistive devices; and
  • Subjects must be ambulatory, and able to walk 350 feet without any assistive devices and climb 2 steps; and
  • Subject must be able to provide identification with photograph; and
  • Female subjects with negative urine pregnancy test performed within 24 hours prior to the clinical PET/CT imaging; and
  • Subject must provide written informed consent; and
  • Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
  • Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
  • Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam

Exclusion Criteria:

  • General Electric Healthcare (GEHC) employees; or
  • GEHC contractors; or
  • Healthcare providers (Any person in a position to purchase, lease, recommend, use, prescribe or arrange for the purchase or lease of any GEHC product or service that is reimbursable under any government program or private health insurance) or employees/contractors of medical device companies (as determined by self-report); or
  • Female subjects with known or suspected pregnancy; or
  • Subjects who have any axial diameter larger than 55 cm; or
  • Subjects with a weight greater than 227 kgs; or
  • Subjects who currently have, or have ever had a Cardiac Pacemaker or Defibrillator with implanted components; or
  • Subjects who are currently undergoing a gastrointestinal study involving swallowing of camera pill or similar device; or
  • Subjects who have any of the conditions below at the time of the scan session:

    • Prior negative experience or problem related to a previous MRI examination
    • Eye injury involving a metallic object
    • Potential for metal to be in body due to a previous injury involving metallic objects
    • Taking fertility medication or having fertility treatment
    • Cochlear, otologic or other ear implant
    • Insulin or other infusion pump
    • Implanted drug infusion device
    • Any type of prosthesis (eye, penile, etc)
    • Swan-Ganz or thermodilution catheter
    • Any metallic fragment or foreign body
    • Artificial or prosthetic limb
    • Bone/joint pin, screw, nail, wire, plate, etc
    • Neurostimulation system
    • Surgical staples, clips, or metallic sutures;
    • Implanted cardioverter defibrillator (ICD);
    • Magnetically activated implant or device;
    • Vascular access port and/or catheter;
    • Medication patch (Nicotine, Nitroglycerine);
    • Internal electrodes or wires;
    • External electronic medical device
    • Bone growth/bone fusion stimulator
    • Radiation seeds or implants
    • Heart valve prosthesis
    • Spinal cord stimulator
    • Eyelid spring or wire
    • Wire mesh implant
    • Tissue expander (e.g. breast)
    • Aneurysm clip(s)
    • Joint replacement (hip, knee, etc…)
    • Vascular or other stent(s), filter(s) or coil(s)
    • Intra-uterine device, diaphragm or pessary
    • Shunt (spinal or intraventricular)
    • Loose dental fillings
    • Dental fillings or crowns placed in the past 30 days
    • Tattoo or permanent makeup
    • Any implant
    • Breathing problem or motion disorder
    • Claustrophobia or panic attacks
    • Hearing Aid
    • Body piercing jewelry
    • Dentures or partial plates
    • External medical hardware (e.g. orthopedic braces)
    • Orthodontic appliances (e.g. braces, expanders)
    • Known or past allergic reactions to latex

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992354


Locations
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United States, Wisconsin
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
GE Healthcare
Investigators
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Principal Investigator: Robert Prost, PhD Froedtert Hospital
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01992354    
Other Study ID Numbers: 114-2013-GES-0012
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Device Product: Yes