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

Primary Purpose

Hydrocephalus, Neurological Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperfine MRI scan
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hydrocephalus focused on measuring MRI, Magnetic Resonance Imaging, CT, Shunt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Outpatients with known or suspected hydrocephalus

Outpatients with other known or suspected neurological condition

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 10, 2020
Last Updated
July 28, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04436068
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Neurological Disorder
Keywords
MRI, Magnetic Resonance Imaging, CT, Shunt

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Outpatients with known or suspected hydrocephalus
Arm Type
Experimental
Arm Title
Outpatients with other known or suspected neurological condition
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hyperfine MRI scan
Intervention Description
Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan.
Primary Outcome Measure Information:
Title
Presence of hydrocephalus
Description
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.
Time Frame
Through study completion, an average of 60 minutes
Title
Quantitative ventricular volumes
Description
Quantitative ventricular volumes (mL) will be obtained and compared for low-field and companion standard clinical MRI scans.
Time Frame
Through study completion, an average of 60 minutes
Title
Presence of other important imaging findings
Description
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.
Time Frame
Through study completion, an average of 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa Sanchez
Phone
215-901-9994
Email
Marisa.Sanchez@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Desiderio
Phone
610-721-3365
Email
lisa.desiderio@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Desiderio
Phone
610-721-3365
Email
lisa.desiderio@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Joel Stein

12. IPD Sharing Statement

Plan to Share IPD
No

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

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