Comparison of Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: Functional MRI (fMRI)

• Registration Number: NCT04172428
• Lead Sponsor: Mayo Clinic

Brief Summary

Comparison of 3 MRI scanners.

Detailed Description

Comparing the strengths and weaknesses of 3 different MRI scanners in their performance of a functional MRI (an MRI that shows which areas in the brain are active during some sort of task).

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2021-02-09
• Status Verified: 2021-03
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Men and Women aged 18-55

Exclusion Criteria

1. Patients with safety contraindications to MRI scanning at 3T.
2. Patients unable to adequately perform the fMRI task due to physical, neurological, or cognitive disability.
3. Patients that demonstrate 3 mm or greater translational head motion during scanning of the fMRI rhyming task data sets.
4. Pregnant women.
5. Patients that have implanted medical devices or other safety contraindications for a 7T or 3T MRI exam.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Functional MRI (fMRI)	Young healthy volunteers between the ages of 18-55.

Primary Outcome Measures

Name	Time	Method
Statistical maxima of fMRI language and motor area activations.	Approximately 6 months after last subject is scanned	For the task-based fMRI comparison, a region of interest will be drawn around activation maps overlying Broca's and Wernicke's language areas as well as the hand motor area. The data regarding each of the three regions will be treated separately. The statistical maxima for functional activation within these areas will be measured and compared using the same areas and technique on the three scanner platforms to determine which is the highest. This will be performed using the PRISM software we already use clinically to interpret fMRI.
Signal to noise ratio assessment of resting state.	Approximately 6 months after last subject is scanned	For the resting state fMRI comparison, a standard measurement of signal to noise ratio will be employed specifically using the default mode network. This data will be reported separately from the task based outcome #1 as they are unrelated. Because this is a ratio is has no units of measurement.

Secondary Outcome Measures

Name	Time	Method
Neuroradiologist preference for scanner array.	Approximately 6 months after last subject is scanned	Two board certified neuroradiologists will simply rank the 3 different scanner platforms (3T, Compact 3T, or the 7T) from most to least preferred for interpreting language and motor task-based fMRI's. This will be their overall qualitative gestalt based on years of daily experience reading these types of studies.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States