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

• ClinicalTrials.gov Identifier: NCT01992354
• Recruitment Status: Terminated
• First Posted: November 25, 2013
• Results First Posted: March 5, 2019
• Last Update Posted: March 19, 2019
• Sponsor: GE Healthcare
• Information provided by (Responsible Party): GE Healthcare

Tracking Information

• First Submitted Date: November 6, 2013
• First Posted Date: November 25, 2013
• Results First Submitted Date: January 15, 2019
• Results First Posted Date: March 5, 2019
• Last Update Posted Date: March 19, 2019
• Study Start Date: November 2013
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2019)

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.

Original Primary Outcome Measures (submitted: November 18, 2013)

Feasibility [ Time Frame: No outcome measurement. Only evaluation of technical image quality after aquistion of image for a given subject. ]

Perform iterative evaluations of the device to optimize device performance and assess feasibility of new features The evaluation is the actual image and how it performs with the software iterations. This is evaluated on an ongoing basis as scans are performed. The evaluation of the images is performed by the subject matter expert who confirms if images are of diagnostic quality and or if there is room for improvement. No diagnosis of the subjects health is performed from these images.

Current Secondary Outcome Measures (submitted: February 12, 2019)

Device Complaints [ Time Frame: One day ]

Number of device complaints reported during a scan

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components
• Official Title: Development of an Integrated PET/MR System, Accessories and Components

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.

• 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Indication for a PET CT Exam

Intervention

Device: PET MR Device

GE PET/MRI system

Study Arms

Experimental: Single Arm

Evaluation of PET MR device for image assessment and device performance

Intervention: Device: PET MR Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 4, 2018): 4
• Original Estimated Enrollment (submitted: November 18, 2013): 150
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01992354
• Other Study ID Numbers: 114-2013-GES-0012
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: GE Healthcare
• Study Sponsor: GE Healthcare
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Prost, PhD; Froedtert Hospital

• PRS Account: GE Healthcare
• Verification Date: March 2019