Clinical trial NCT05425927: Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
Official title: Validation of 3D Synthetic MRI for Neuroimaging - Prospective, Multicenter, Multireader Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Indication for Brain MRI
Healthy Volunteers
Keywords: neuroimaging
Lead sponsor: SyntheticMR
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 189
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: DIAGNOSTIC

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Pathological Findings (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Specificity of Pathological Findings (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Secondary outcomes:
measure: Classification of Pathological Findings
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Sensitivity (Adult Population)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Selectivity (Adult Population)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Classification of Pathological Findings (Adult Population)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Sensitivity (Pediatric Population)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Selectivity (Pediatric Population)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Classification of Pathological Findings (Pediatric Population)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Other outcomes:
measure: Legibility T1w (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Legibility T2w (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Artifacts T1w(Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Artifacts T2w(Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Inter-rater Agreement (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Inter-method Agreement (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Image Quality Score (Full Analysis Set)
timeFrame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
measure: Safety (Full Analysis Set)
timeFrame: Exam day (1 day), Generation of Synthetic Images (up to 7 weeks)
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's hospital
state: Arizona
city: Naples
country: United States
facility: ProScan Imaging
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Health, Nemours Children's Hospital, Florida
state: Florida
city: Chicago
country: United States
facility: SimonMed imaging Streeterville
state: Illinois
city: New York
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Seattle
country: United States
facility: Diagnostic Imaging Sciences Center (DISC) University of Washington Medical Center (UWMC)
state: Washington
Study officials:
affiliation: Phoenix Children's Hospital
name: Jeffrey H Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: