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
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- Diagnostic Image Quality [ Time Frame: through study completion, an average of 2 months ]
scored on a 5-pt Likert scale:
- 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.
- Summary of Safety Information [ Time Frame: through study completion, an average of 2 months ]Number of safety events (AEs and SAEs).
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Director:||Tibor Duliskovich, M.D.||GE Healthcare, Medical Monitor|