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

NCT04172428 | Completed FDA Device

• 1 other identifier: 19-004228
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of 3 MRI scanners.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Neuroradiologist preference for scanner array.

  Approximately 6 months after last subject is scanned

Study Arms (1)

Healthy volunteers

Young healthy volunteers between the ages of 18-55.

Diagnostic Test: Functional MRI (fMRI)

Interventions

Functional MRI (fMRI) DIAGNOSTIC_TEST

fMRI will be done on 3 separate MRI scanners to compare.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \) Men and Women aged 18-55

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• David F Black, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: November 21, 2019
• Study Start: February 9, 2021
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)