Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-07-31

Brief Summary

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This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,

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Detailed Description

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This study is a prospective, blinded, multi-center, multi-reader clinical study that is statistically powered for demonstrating non-inferiority of synthetic 3D MR images compared to conventional MR images with respect to sensitivity and specificity of pathological findings.

The study consists of three parts:

* Clinical MR acquisition,
* Synthetic MR post-processing
* Blinded image evaluation of conventional and synthetic images for each subject.

The study will enroll eligible subjects with an already scheduled brain MRI and also healthy volunteers, that meet applicable site MR safety criteria. The routine MRI scan will include approximately 5-20 minutes extra time for the additional images to be taken. This time will be added to the length of the scheduled scan. It is only the time in the MRI scanner that will differ from standard procedures, no other examinations will be performed.

The study consists of one visit, without additional follow-up.

Conditions

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Clinical Indication for Brain MRI Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects will be enrolled from the general imaging population scheduled for an MRI of the brain and healthy volunteers, using the scanner available at the investigational sites. A conventional MRI scan of the brain is taken, and an additional sequence that is processed into synthetic MR images. The conventional and the synthetic MR images from the same subject is compared.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

For each subject, conventional and synthetic images will be assessed by blinded, experienced neuroradiologists who will assess the images with regards to radiological findings, image quality, legibility of anatomical structures, and artifacts. The readings will be separated into two reading sessions with a 4-week memory-washout period.

Study Groups

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Neurologic Synthetic and Conventional MRI

MR images of the brain acquired for post-processing with software (SyMRI 15, 3D).

Comparison is done between the conventional MR images and the post-processed synthetic MR images

Group Type EXPERIMENTAL

SyMRI 15 (3D)

Intervention Type DEVICE

Neurological MRI image collection

Interventions

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SyMRI 15 (3D)

Neurological MRI image collection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any gender, aged 0-99 years
* Subject scheduled for MRI of the brain OR Healthy control with passed screening form
* Subject suitable for MRI as judged by investigator
* Subject agrees to 5-20 min extra MRI scan time
* Subject able to understand written and verbal information in English or Spanish
* Provision of informed consent (and assent if applicable)

Exclusion Criteria

* Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site
* Have severe trauma, disability or pre-existing pathology that is expected to interfere with normal conduct of MRI scanning or complete scanning of the brain
* Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician investigator, would prevent safe participation in the study
* Adult subjects (aged 18-99 years) in need of anesthesia during MRI scanning
* Pregnancy at time of enrollment determined according to the clinic's MR Safety Screening policy
* Previous enrollment in this investigation

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes