Hyperfine Portable MRI in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging

NCT04436068 | Active Not Recruiting FDA Device

• 1 other identifier: 832913
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Participants with known or suspected hydrocephalus will receive brain scans using the Hyperfine, low field strength, portable, magnetic resonance imaging (MRI) system in addition to their scheduled outpatient standard of care clinical computed tomography (CT) or MRI scan. The purpose of this pilot study is to evaluate the feasibility and acceptability of using the Hyperfine system in an outpatient setting and to compare its diagnostic performance to standard clinical imaging. Outpatients with other known or suspected neurological disorders or conditions prompting routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic performance of low field scans compared to that of the same day standard of care clinical imaging.

Conditions

Hydrocephalus; Neurological Disorder

Keywords

MRI; Magnetic Resonance Imaging; CT; Shunt

Outcome Measures

Primary Outcomes (3)

• Presence of hydrocephalus

  Presence or absence of hydrocephalus will be determined qualitatively based on neuroradiologist interpretation of low-field MRI scans and companion standard clinical MRI or CT scans to evaluate performance using the low-field device to make this determination.

  Through study completion, an average of 60 minutes

• Quantitative ventricular volumes

  Quantitative ventricular volumes (mL) will be obtained and compared for low-field and companion standard clinical MRI scans.

  Through study completion, an average of 60 minutes

• Presence of other important imaging findings

  Presence of other important imaging findings will be determined qualitatively based on neuroradiologist interpretation of low-field MRI scans and companion standard clinical MRI or CT scans.

  Through study completion, an average of 60 minutes

Study Arms (2)

Outpatients with known or suspected hydrocephalus

EXPERIMENTAL

Device: Hyperfine MRI scan

Outpatients with other known or suspected neurological condition

EXPERIMENTAL

Device: Hyperfine MRI scan

Interventions

Hyperfine MRI scan DEVICE

Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan.

Outpatients with known or suspected hydrocephalus; Outpatients with other known or suspected neurological condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Suspected or confirmed diagnosis of hydrocephalus from Penn referring physician
• Other suspected or confirmed neurological disorder from Penn referring physician
• Routine clinical CT or MRI of the brain scheduled/obtained on the same day as Hyperfine imaging.
• Informed consent obtained from patient or legally authorized representative

You may not qualify if:

• Contraindications to routine 1.5T MRI evaluation, including electrical implants such as cardiac pacemakers or perfusion pumps, ferromagnetic implants such as aneurysm clips, surgical clips, protheses, artificial hearts or heart valves with steel parts, metal fragments, shrapnel, tattoos near the eye, steel implants, or other irremovable ferromagnetic objects
• History of uncontrolled seizures
• Claustrophobia
• Weight greater than or equal to 400lbs (181.4kg)
• Pregnancy
• Inability or suspected inability to comply with the study procedures

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hydrocephalus; Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 17, 2020
• Study Start: June 28, 2019
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)