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CompletedNCT02927327Updated Dec 6, 2018Results posted

Clinical Evaluation Of MP26 Features in Adults

An interventional study of Zero Echo Time (ZTE) scan for head attenuation and Q.Static (Q. MRAC) for respiratory motion correction in Brain Imaging and Whole Body Imaging, sponsored by GE Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-06.

Sponsored by GE Healthcare · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. The images and summary data from this study are intended for use in regulatory submission.

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.

02

Conditions studied

  • Brain Imaging
  • Whole Body Imaging
03

In context

Lead sponsor

GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Are adults (aged 18 or older);
  2. 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);
  3. Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
  4. Can hear without assistive devices and have necessary mental capacity to follow study instructions;
  5. Are willing and able to provide written informed consent;
  6. Are considered eligible for MRI and PET exams, according to site institutional safety policies.

Exclusion criteria

Exclusion Criteria:

  1. Were previously enrolled in the study;
  2. If female, are pregnant or of undetermined pregnancy status;
  3. Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
  4. Have implants or attached medical devices that could be unsafe for MRI;
  5. Have medical conditions or require urgent care that could make it unsafe to participate
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    PET/MR ZTE MRAC

    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

    Device: Zero Echo Time (ZTE) scan for head attenuation

  • Experimental
    PET/MR Q Static (Q. MRAC)

    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)

    Device: Q.Static (Q. MRAC) for respiratory motion correction

Interventions

  • DeviceZero Echo Time (ZTE) scan for head attenuation

    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

  • DeviceQ.Static (Q. MRAC) for respiratory motion correction

    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)

06

What researchers measure

Primary outcomes

  1. Diagnostic Image Quality

    scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent

    Time frame: through study completion, an average of 2 months

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 2 months

  2. 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.

    Time frame: through study completion, an average of 2 months

  3. 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.

    Time frame: through study completion, an average of 2 months

Other outcomes

  1. Summary of Safety Information

    Number of safety events (AEs and SAEs).

    Time frame: through study completion, an average of 2 months

07

Results

Posted Dec 6, 2018

Participant flow

Participant flow — Overall Study
MilestonePET/MR ZTE MRACPET/MR Q Static (Q. MRAC)
Started3031
Completed3031
Not completed00

Outcome measures

PrimaryDiagnostic Image Quality

scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent

Time frame:
through study completion, an average of 2 months
Reported as:
Mean · scores on a scale
Diagnostic Image Quality
scores on a scalePET/MR ZTE MRACPET/MR Q Static (Q. MRAC)
Diagnostic Image Quality4.4 ± 0.543.9 ± 0.68
SecondaryDetermination 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.

Time frame:
through study completion, an average of 2 months
Reported as:
Count of participants · Participants
Determination of Diagnostic Acceptability
ParticipantsPET/MR ZTE MRACPET/MR Q Static (Q. MRAC)
Determination of Diagnostic Acceptability3031
SecondaryEase 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.

Time frame:
through study completion, an average of 2 months
Reported as:
Mean · scores on a scale
Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
scores on a scalePET/MR ZTE MRACPET/MR Q Static (Q. MRAC)
Prescribing PET scan4.6 ± 0.734.6 ± 0.73
Prescribing MR scans simultaneous with PET4.6 ± 0.734.6 ± 0.73
Starting and monitoring scanning4.6 ± 0.814.6 ± 0.81
Reviewing PET and MR images4.6 ± 0.734.6 ± 0.73
Overall process of doing this exam4.6 ± 0.784.6 ± 0.78
Performing exam within acceptable duration to meet4.6 ± 0.854.6 ± 0.85
SecondaryNumber 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.

Time frame:
through study completion, an average of 2 months
Reported as:
Count of participants · Participants
Number of Participants Reporting "Yes" On All Binary Performance Scale Questions
ParticipantsPET/MR ZTE MRACPET/MR Q Static (Q. MRAC)
Number of Participants Reporting "Yes" On All Binary Performance Scale Questions3031
Other pre-specifiedSummary of Safety Information

Number of safety events (AEs and SAEs).

Time frame:
through study completion, an average of 2 months

Results for this outcome have not been posted.

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PET/MR ZTE MRAC0/30 (0%)0/30 (0%)0/30 (0%)
PET/MR Q Static (Q. MRAC)0/31 (0%)0/31 (0%)0/31 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PET/MR ZTE MRACPET/MR Q Static (Q. MRAC)Total
<=18 years000
Between 18 and 65 years171128
>=65 years132033
Age, Continuous
Age, Continuous(years)PET/MR ZTE MRACPET/MR Q Static (Q. MRAC)Total
Mean60.6 ± 12.8667.3 ± 10.7664.0 ± 12.21
Sex: Female, Male
Sex: Female, Male(Participants)PET/MR ZTE MRACPET/MR Q Static (Q. MRAC)Total
Female121426
Male181735
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)PET/MR ZTE MRACPET/MR Q Static (Q. MRAC)Total
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)PET/MR ZTE MRACPET/MR Q Static (Q. MRAC)Total
United States303161
08

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 30, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02927327
Lead sponsor
GE Healthcare
Responsible party
Sponsor
First posted
Oct 7, 2016
Start date
Nov 2016
Primary completion
Sep 20, 2017
Completion
Sep 20, 2017
Results posted
Dec 6, 2018
Last update
Dec 6, 2018

Study contacts

Tibor Duliskovich, M.D.
study director · GE Healthcare, Medical Monitor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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