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

Comparison of 3 MRI scanners.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Functional MRI (fMRI)

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young healthy volunteers ages 18-55, English must be primary language

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; Young healthy volunteers between the ages of 18-55.	Diagnostic test: Functional MRI (fMRI); fMRI will be done on 3 separate MRI scanners to compare.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical maxima of fMRI language and motor area activations.	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.	Approximately 6 months after last subject is scanned
Signal to noise ratio assessment of resting state.	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.	Approximately 6 months after last subject is scanned

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroradiologist preference for scanner array.	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.	Approximately 6 months after last subject is scanned

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David F Black, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2021
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ACTUAL): March 15, 2021

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 19-004228

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No