Low Field Magnetic Resonance Imaging Assessment With Outpatients

NCT ID: NCT05582785

Last Updated: 2025-02-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-12-31

Brief Summary

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The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength.

Detailed Description

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Conditions

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Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hyperfine

For patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams.

Group Type EXPERIMENTAL

Hyperfine MRI

Intervention Type DIAGNOSTIC_TEST

Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.

Interventions

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Hyperfine MRI

Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Outpatients at CMH Adele Hall Radiology ages 0 days to 22 years are eligible for enrollment.

Exclusion Criteria

No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.

Any patient who has a contraindication to having an MRI, such as:

Non-MRI conditional implanted device or device that is not able to be removed for MRI examination
Minimum Eligible Age

0 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Sherwin Chan MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherwin Chan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy

Locations

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Children's Mercy Kansas City

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maura Sien, MS, RT(R)

Role: CONTACT

8163026065

Sarah Foster

Role: CONTACT

8162343273

Facility Contacts

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Maura Sien

Role: primary

8163026065

Amie Robinson

Role: backup

8163028311

Other Identifiers

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STUDY00002266

Identifier Type: -

Identifier Source: org_study_id

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