Any Condition With a Clinical Indication for PET/CT ExamPET/MR USNCT01986985
Comparison of 18F FDG PET/CT TO PET MRI
A study testing PET/MRI system in people with Any Condition With a Clinical Indication for PET/CT Exam, run by GE Healthcare at 2 sites in United States.
Trial summary
The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Condition With a Clinical Indication for PET/CT Exam
- What is being tested?
- PET/MRI system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Jul 2014
- 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
- Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging
- Subject must be able to hear and understand instructions without assistive devices
- Subject must provide written informed consent
- Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements
- 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
- Subjects who have any axial diameter larger than 55 cm
- Subjects with a weight greater than 499 lbs
- Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator
- Subjects that have implants with MR Unsafe labeling;
- Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol;
- Subjects who have a contraindication to MRI per the screening policy of the participating site.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California - San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
About this study
The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. These aims can only be accomplished through a clinical study.
- Being tested
- PET/MRI system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI systemDevice
Also called PET/MRI system inlcudes:, 3T MR750w Magnet, MR750w XRMw Gradient, PET/MRI Body Coil
Compared to PET CT
| Study group | Role | What they receive |
|---|---|---|
| Single arm PET MRI | Other | single group evaluation of PET/MRI system scan for diagnostic quality of image Receives: Device: PET/MRI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/MR Images Clinical Usefulness
Clinically relevant images are obtained
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJul 2014
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 Any Condition With a Clinical Indication for 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roee Lazebnik, MD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986985
- Sponsor's protocol ID
- 114-2013-GES-0014
- Acronym
- PET/MR US
- Status last verified
- Feb 2016
- First submitted
- 6 Nov 2013
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18F FDG PET/CT TO PET MRI
- ClinicalTrials.gov ID
- NCT01986985
- Acronym / sponsor ID
- PET/MR US / 114-2013-GES-0014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. These aims can only be accomplished through a clinical study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm PET MRI | Other | Device: PET/MRI systemsingle group evaluation of PET/MRI system scan for diagnostic quality of image |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must have a clinical indication for a PET/CT exam
- Subject must be at least eighteen (18) years of age
- Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging
- Subject must be able to hear and understand instructions without assistive devices
- Subject must provide written informed consent
Key exclusion criteria (6 listed)
- Subjects who have any axial diameter larger than 55 cm
- Subjects with a weight greater than 499 lbs
- Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator
- Subjects that have implants with MR Unsafe labeling;
- Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol;
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/MRI systemAlso: PET/MRI system inlcudes:, 3T MR750w Magnet, MR750w XRMw Gradient, PET/MRI Body CoilCompared to PET CT | Device | Single arm PET MRI |
Primary outcome
PET/MR Images Clinical Usefulness
Time frame: 1 day
Clinically relevant images are obtained
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Roee Lazebnik, MD study director
GE Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI system in people with Any Condition With a Clinical Indication for PET/CT Exam, run by GE Healthcare at 2 sites 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 May 2015). 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 Images Clinical Usefulness (time frame: 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 7 Mar 2016.