Subjects With Clinical Indication for PET/CTPET/MR_ZURICHNCT02071706
Clinical Evaluation of an Integrated PET/MRI System
A study testing PET/MRI system in people with Subjects With Clinical Indication for PET/CT, run by GE Healthcare at 1 site in Switzerland.
Trial summary
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects With Clinical Indication for PET/CT
- 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
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Aug 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; and
- 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; and
- Subject must be able to hear and understand instructions without assistive devices; 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 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.
Who cannot join
- Subjects who have any axial diameter larger than 55 cm; or
- Subjects with a weight greater than 227 kgs; or
- 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; or
- Subjects that have implants with MR Unsafe labeling; or
- 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 ; or
- Subjects who have a contraindication to MRI according to the screening policy of the participating site
Trial locations and contacts
1 site in 1 country.
About this study
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
- 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
Enrolled subject undergoes PET/MR scan
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm PET/MRI | Other | Single-group evaluation of PET/MRI 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.
Number Usable PET/MRI Image Sets
The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale
Measured: 1 day
Number of Diagnostic Quality Images
Number of images sets deemed diagnostic quality by the investigator
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 posted26 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 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 Subjects With Clinical Indication for PET/CTStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibor Duliskovich, Medical Doctor, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071706
- Sponsor's protocol ID
- 114-2013-GES-0010
- Acronym
- PET/MR_ZURICH
- Status last verified
- Jan 2019
- First submitted
- 23 Feb 2014
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Integrated PET/MRI System
- ClinicalTrials.gov ID
- NCT02071706
- Acronym / sponsor ID
- PET/MR_ZURICH / 114-2013-GES-0010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
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 PET/MRI | Other | Device: PET/MRI systemSingle-group evaluation of PET/MRI 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; and
- 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; and
- Subject must be able to hear and understand instructions without assistive devices; and
- Subject must provide written informed consent; and
Key exclusion criteria (6 listed)
- Subjects who have any axial diameter larger than 55 cm; or
- Subjects with a weight greater than 227 kgs; or
- 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; or
- Subjects that have implants with MR Unsafe labeling; or
- 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 ; 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/MRI systemAlso: PET/MRI system inlcudes:, 3T MR750w Magnet, MR750w XRMw Gradient, PET/MRI Body CoilEnrolled subject undergoes PET/MR scan | Device | Single-Arm PET/MRI |
Primary outcome
Number Usable PET/MRI Image Sets
Time frame: 1 day
The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale
Number of Diagnostic Quality Images
Time frame: 1 day
Number of images sets deemed diagnostic quality by the investigator
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- 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.
Tibor Duliskovich, Medical Doctor study director
GE Healthcare
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/MRI system in people with Subjects With Clinical Indication for PET/CT, run by GE Healthcare at 1 site in Switzerland.
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 8 Apr 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 Switzerland. 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 8 Apr 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?
Number Usable PET/MRI Image Sets (time frame: 1 day). The study lists 2 primary outcomes in all. 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 8 Apr 2019.