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Clinical Evaluation Of MP26 Features in Adults

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ClinicalTrials.gov Identifier: NCT02927327
Recruitment Status : Completed
First Posted : October 7, 2016
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Imaging Whole Body Imaging Device: Zero Echo Time (ZTE) scan for head attenuation Device: Q.Static (Q. MRAC) for respiratory motion correction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Evaluation Of MP26 Features in Adults
Study Start Date : November 2016
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Arm Intervention/treatment
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

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


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

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)





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Determination of Diagnostic Acceptability [ Time Frame: through study completion, an average of 2 months ]
    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.

  2. Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score [ Time Frame: through study completion, an average of 2 months ]
    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.

  3. Number of Participants Reporting "Yes" On All Binary Performance Scale Questions [ Time Frame: through study completion, an average of 2 months ]
    The number of participants reporting "yes" on a binary performance scale (Y/N) were collected.


Other Outcome Measures:
  1. Summary of Safety Information [ Time Frame: through study completion, an average of 2 months ]
    Number of safety events (AEs and SAEs).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927327


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Tibor Duliskovich, M.D. GE Healthcare, Medical Monitor
  Study Documents (Full-Text)

Documents provided by GE Healthcare:

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02927327     History of Changes
Other Study ID Numbers: 114.03-2016-GES-0001
First Posted: October 7, 2016    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No