Safety and Feasibility of Imaging at 10.5 Tesla

NCT ID: NCT03346707

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2022-09-01

Brief Summary

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This unique NMR instrument is the first of its kind, and the most advanced system that is capable of brain, torso and extremity imaging in humans at such a high magnetic field. It will be transformative in performance relative to 7Tesla, and significantly expand the capabilities of multinuclear MRI, fMRI, morphological imaging, MRS etc. in the human brain and body.

In addition, to the known and potential benefits of performing anatomic and functional imaging studies at 10.5T, there are also known short-term side effects associated with subjecting humans to such high magnetic fields. This protocol will study the magnitude and variability of the short term and long term physiological, cognitive and vestibular effects while also assessing the feasibility of acquiring the types of data needed for translating research protocols onto this higher field strength scanner.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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10.5 Tesla

10.5 Tesla

Intervention Type DEVICE

10.5Tesla MR scan

Interventions

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10.5 Tesla

10.5Tesla MR scan

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 and 70
2. Able to self-consent
3. Weight less than 190 pounds
4. Participated in high field MRI studies (7T or higher)

Exclusion Criteria

Subjects with metallic, magnetic, and/or electrically conductive implants or external devices.

1. Ferromagnetic implants
2. Any foreign metal objects in the body
3. History of shrapnel or shot gun injury
4. Cardiac pacemakers
5. Defibrillator
6. Neuronal stimulator
7. Magnetic aneurysm clip
8. Large tattoos on the abdomen or the brain and neck
9. Hip replacement
10. Too large to fit in the magnet (body mass index \>= 40, approx.)
11. Severe claustrophobia
12. Women who are pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMMR

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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RAD-2017-24570

Identifier Type: -

Identifier Source: org_study_id

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