Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components
Stopped early · Not applicable
Conditions studied: Indication for a PET CT Exam
In brief
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.
Key facts
- Study ID
- NCT01992354
- Run by
- GE Healthcare
- People needed
- 4
- Starts
- 2013-11-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2019-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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;
Where it is running
- Froedtert Hospital — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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