Indication for a PET CT ExamNCT01992354
Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components
A study testing PET MR Device in people with Indication for a PET CT Exam, run by GE Healthcare at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication for a PET CT Exam
- What is being tested?
- PET MR Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Indication for a PET CT Exam
- Being tested
- PET MR Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET MR DeviceDevice
GE PET/MRI system
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Evaluation of PET MR device for image assessment and device performance Receives: Device: PET MR Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One (1) day
Secondary outcomes (1)
Device Complaints
Number of device complaints reported during a scan
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Indication for a PET CT ExamStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Prost, PhD, Principal investigator, Froedtert Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992354
- Sponsor's protocol ID
- 114-2013-GES-0012
- Status last verified
- Mar 2019
- First submitted
- 6 Nov 2013
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Integrated PET/MR System, Accessories and Components
- ClinicalTrials.gov ID
- NCT01992354
- Acronym / sponsor ID
- 114-2013-GES-0012
- Conditions
- Indication for a PET CT Exam
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: PET MR DeviceEvaluation of PET MR device for image assessment and device performance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (53 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET MR DeviceGE PET/MRI system | Device | Single Arm |
Primary outcome
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.
1 secondary outcome
Device Complaints
Time frame: One day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Cardiac Inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Prost, PhD principal investigator
Froedtert Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET MR Device in people with Indication for a PET CT Exam, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET/MR Scan Obtained (time frame: One (1) day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.