N/A
N=61
Clinical Evaluation Of MP26 Features in Adults
Brain Imaging · Whole Body Imaging
Bottom Line
View on ClinicalTrials.gov: NCT02927327 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Diagnostic Image Quality — 4.4; 3.9 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zero Echo Time (ZTE) scan for head attenuation (Device); Q.Static (Q. MRAC) for respiratory motion correction (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Image Quality |
4.4; 3.9 | — |
| SECONDARY Determination of Diagnostic Acceptability |
30; 31 | — |
| SECONDARY Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score |
4.6; 4.6; 4.6; 4.6; 4.6; 4.6 | — |
| SECONDARY Number of Participants Reporting "Yes" On All Binary Performance Scale Questions |
30; 31 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02927327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.