Brain ImagingNCT02927327

Clinical Evaluation Of MP26 Features in Adults

A study testing Zero Echo Time (ZTE) scan for head attenuation and Q.Static (Q. MRAC) for respiratory motion correction in people with Brain Imaging and Whole Body Imaging, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Imaging, Whole Body Imaging
What is being tested?: Zero Echo Time (ZTE) scan for head attenuation and Q.Static (Q. MRAC) for respiratory motion correction
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Nov 2016to 20 Sep 2017
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

Are adults (aged 18 or older);
Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required);
Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
Can hear without assistive devices and have necessary mental capacity to follow study instructions;
Are willing and able to provide written informed consent;
Are considered eligible for MRI and PET exams, according to site institutional safety policies.

Who cannot join

Were previously enrolled in the study;
If female, are pregnant or of undetermined pregnancy status;
Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
Have implants or attached medical devices that could be unsafe for MRI;
Have medical conditions or require urgent care that could make it unsafe to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Read the detailed description

Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population.

Secondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites.

Safety Objective(s): To collect information about safety events and device issues.

Conditions: Brain Imaging, Whole Body Imaging
Being tested: Zero Echo Time (ZTE) scan for head attenuation, Q.Static (Q. MRAC) for respiratory motion correction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zero Echo Time (ZTE) scan for head attenuationDevice
The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.
PET/MR ZTE MRAC
Q.Static (Q. MRAC) for respiratory motion correctionDevice
An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.
PET/MR Q Static (Q. MRAC)

Study groups in NCT02927327
Study group	Role	What they receive
PET/MR ZTE MRAC	Experimental	PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment. Zero Echo Time (ZTE) scan for head attenuation Receives: Device: Zero Echo Time (ZTE) scan for head attenuation
PET/MR Q Static (Q. MRAC)	Experimental	Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment. PET/MR Q Static (Q. MRAC) Receives: Device: Q.Static (Q. MRAC) for respiratory motion correction

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Image Quality
scored on a 5-pt Likert scale:
1. Unacceptable
2. Poor
3. Acceptable
4. Good
5. Excellent
Measured: through study completion, an average of 2 months

Secondary outcomes (3)

Determination of Diagnostic Acceptability
Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.
Measured: through study completion, an average of 2 months
Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study.
Measured: through study completion, an average of 2 months
Number of Participants Reporting "Yes" On All Binary Performance Scale Questions
The number of participants reporting "yes" on a binary performance scale (Y/N) were collected.
Measured: through study completion, an average of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201620 Sep 2017

First posted7 Oct 2016 (estimated)
Study startNov 2016
Primary completion20 Sep 2017
Study completion20 Sep 2017

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 Brain ImagingStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02927327
Sponsor's protocol ID: 114.03-2016-GES-0001
Status last verified: Dec 2018
First submitted: 4 Oct 2016
Last updated: 6 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation Of MP26 Features in Adults
ClinicalTrials.gov ID: NCT02927327
Acronym / sponsor ID: 114.03-2016-GES-0001
Conditions: Brain Imaging, Whole Body Imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: 20 Sep 2017 (actual)
Study completion: 20 Sep 2017 (actual)
First posted: 7 Oct 2016 (estimated)
Results: Posted 6 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population.

Secondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites.

Safety Objective(s): To collect information about safety events and device issues.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PET/MR ZTE MRAC	Experimental	Device: Zero Echo Time (ZTE) scan for head attenuationPET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment. Zero Echo Time (ZTE) scan for head attenuation
PET/MR Q Static (Q. MRAC)	Experimental	Device: Q.Static (Q. MRAC) for respiratory motion correctionQ.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment. PET/MR Q Static (Q. MRAC)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Are adults (aged 18 or older);
Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required);
Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
Can hear without assistive devices and have necessary mental capacity to follow study instructions;
Are willing and able to provide written informed consent;

Key exclusion criteria (5 listed)

Were previously enrolled in the study;
If female, are pregnant or of undetermined pregnancy status;
Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
Have implants or attached medical devices that could be unsafe for MRI;
Have medical conditions or require urgent care that could make it unsafe to participate

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
Zero Echo Time (ZTE) scan for head attenuationThe GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR. PET/MR ZTE MRAC	Device	PET/MR ZTE MRAC
Q.Static (Q. MRAC) for respiratory motion correctionAn improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images. PET/MR Q Static (Q. MRAC)	Device	PET/MR Q Static (Q. MRAC)

Primary outcome

Diagnostic Image Quality
Time frame: through study completion, an average of 2 months
scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent

3 secondary outcomes

Determination of Diagnostic Acceptability
Time frame: through study completion, an average of 2 months
Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
Time frame: through study completion, an average of 2 months
Number of Participants Reporting "Yes" On All Binary Performance Scale Questions
Time frame: through study completion, an average of 2 months

Results and safety

Results posted to the registry on 6 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PET/MR ZTE MRAC	30	30
PET/MR Q Static (Q. MRAC)	31	31

Primary outcome: Diagnostic Image Quality

Time frame: through study completion, an average of 2 months. Mean (Standard Deviation). Unit: scores on a scale

Measure	PET/MR ZTE MRAC n = 30	PET/MR Q Static (Q. MRAC) n = 31
Value	4.4 (0.54)	3.9 (0.68)

Population analysed: Subjects that had a clinical indication for PET/CT or PET/MR with radiotracer injection prescribed for their medical care outside of the study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were reported from the time the subject entered the PET/MR suite until the subject left the PET/MR suite, an average of less than 2 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PET/MR ZTE MRAC	0 of 30 (0%)	0 of 30 (0%)	0 of 30
PET/MR Q Static (Q. MRAC)	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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, M.D. study director

GE Healthcare, Medical Monitor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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 6 Dec 2018. 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 6 Dec 2018). 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?

Diagnostic Image Quality (time frame: through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927327.

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 6 Dec 2018.