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

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.

Study Overview

• Status: Terminated
• Conditions: Indication for a PET CT Exam
• Intervention / Treatment: Device: PET MR Device

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Complaints	Number of device complaints reported during a scan	One day

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Robert Prost, PhD, Froedtert Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 114-2013-GES-0012

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes