Hyperfine Portable MRI in Hydrocephalus

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Brief Title

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

Official Title

Evaluation of Hyperfine Low Field Strength Portable Point-of-Care Magnetic Resonance Imaging System in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging

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.
    

Detailed Description

      Hydrocephalus is a medical condition in which an abnormal buildup of cerebrospinal fluid
      (CSF) causes the fluid-filled spaces of the brain, the ventricles, to become enlarged.
      Enlarged ventricles and increased intracranial pressure can cause headaches, dizziness,
      blurred vision, cognitive impairment, gait disturbances and in severe cases even brain
      herniation or death. A tube or shunt can be inserted into the ventricles to drain the CSF
      either outside the body temporarily or into the abdominal cavity for long-term treatment.
      Sometimes such shunts need to be adjusted or replaced if fluid re-accumulates. Medical
      imaging scans, either computer tomography (CT) or magnetic resonance imaging (MRI), are used
      to diagnose hydrocephalus in adults and children.

      The purpose of this pilot study is to assess the performance of a newly developed, portable,
      low-cost MRI machine (Hyperfine MRI) in diagnosing and following patients with hydrocephalus
      in comparison to routine clinical CT or MRI. Outpatients with known or suspected
      hydrocephalus with or without ventricular shunts will be recruited to undergo Hyperfine MRI
      in conjunction with their routine clinical imaging. We will evaluate both the feasibility and
      acceptability of using the Hyperfine unit in the outpatient setting as well as the
      performance of Hyperfine MRI images in identifying hydrocephalus and other key brain imaging
      features relative to routine CT and MRI.

      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.
    


Study Type

Interventional


Primary Outcome

Presence of hydrocephalus


Condition

Hydrocephalus

Intervention

Hyperfine MRI scan

Study Arms / Comparison Groups

 Outpatients with known or suspected hydrocephalus
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

June 28, 2019

Completion Date

December 2023

Primary Completion Date

June 2023

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 215-901-9994, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04436068

Organization ID

832913


Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania


Study Sponsor

, , 


Verification Date

July 2022