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OpenTrials
Completed

NCT Number: NCT02927327

Clinical Evaluation Of MP26 Features in Adults

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.

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Key information

Conditions

Brain Imaging Whole Body Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Zero Echo Time (ZTE) scan for head attenuation

Device

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 correction

Device

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 outcomes

  1. Diagnostic Image Quality

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

    scored on a 5-pt Likert scale:

    • Unacceptable
    • Poor
    • Acceptable
    • Good
    • Excellent

Secondary outcomes

  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 outcomes

  1. Summary of Safety Information

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

    Number of safety events (AEs and SAEs).

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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