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Clinical Evaluation Of MP26 Features in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 4, 2016
First Posted Date  ICMJE October 7, 2016
Results First Submitted Date  ICMJE July 26, 2018
Results First Posted Date  ICMJE December 6, 2018
Last Update Posted Date December 6, 2018
Study Start Date  ICMJE November 2016
Actual Primary Completion Date September 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
Determination of Diagnostic Acceptability [ Time Frame: through study completion, an average of 2 months ]
Rated on a binary (Y/N) performance scale
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2016)
Summary of Safety Information [ Time Frame: through study completion, an average of 2 months ]
Number of safety events (AEs and SAEs).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation Of MP26 Features in Adults
Official Title  ICMJE Clinical Evaluation Of MP26 Features in Adults
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Brain Imaging
  • Whole Body Imaging
Intervention  ICMJE
  • 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

  • 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)

Study Arms  ICMJE
  • 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

    Intervention: 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)

    Intervention: Device: Q.Static (Q. MRAC) for respiratory motion correction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
61
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
75
Actual Study Completion Date  ICMJE September 20, 2017
Actual Primary Completion Date September 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02927327
Other Study ID Numbers  ICMJE 114.03-2016-GES-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tibor Duliskovich, M.D. GE Healthcare, Medical Monitor
PRS Account GE Healthcare
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP