<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04436068</url>
  </required_header>
  <id_info>
    <org_study_id>832913</org_study_id>
    <nct_id>NCT04436068</nct_id>
  </id_info>
  <brief_title>Hyperfine Portable MRI in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants with known or suspected hydrocephalus will receive brain scans using the&#xD;
      Hyperfine, low field strength, portable, magnetic resonance imaging (MRI) system in addition&#xD;
      to their scheduled outpatient standard of care clinical computed tomography (CT) or MRI scan.&#xD;
      The purpose of this pilot study is to evaluate the feasibility and acceptability of using the&#xD;
      Hyperfine system in an outpatient setting and to compare its diagnostic performance to&#xD;
      standard clinical imaging.&#xD;
&#xD;
      Outpatients with other known or suspected neurological disorders or conditions prompting&#xD;
      routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic&#xD;
      performance of low field scans compared to that of the same day standard of care clinical&#xD;
      imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hydrocephalus is a medical condition in which an abnormal buildup of cerebrospinal fluid&#xD;
      (CSF) causes the fluid-filled spaces of the brain, the ventricles, to become enlarged.&#xD;
      Enlarged ventricles and increased intracranial pressure can cause headaches, dizziness,&#xD;
      blurred vision, cognitive impairment, gait disturbances and in severe cases even brain&#xD;
      herniation or death. A tube or shunt can be inserted into the ventricles to drain the CSF&#xD;
      either outside the body temporarily or into the abdominal cavity for long-term treatment.&#xD;
      Sometimes such shunts need to be adjusted or replaced if fluid re-accumulates. Medical&#xD;
      imaging scans, either computer tomography (CT) or magnetic resonance imaging (MRI), are used&#xD;
      to diagnose hydrocephalus in adults and children.&#xD;
&#xD;
      The purpose of this pilot study is to assess the performance of a newly developed, portable,&#xD;
      low-cost MRI machine (Hyperfine MRI) in diagnosing and following patients with hydrocephalus&#xD;
      in comparison to routine clinical CT or MRI. Outpatients with known or suspected&#xD;
      hydrocephalus with or without ventricular shunts will be recruited to undergo Hyperfine MRI&#xD;
      in conjunction with their routine clinical imaging. We will evaluate both the feasibility and&#xD;
      acceptability of using the Hyperfine unit in the outpatient setting as well as the&#xD;
      performance of Hyperfine MRI images in identifying hydrocephalus and other key brain imaging&#xD;
      features relative to routine CT and MRI.&#xD;
&#xD;
      Outpatients with other known or suspected neurological disorders or conditions prompting&#xD;
      routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic&#xD;
      performance of low field scans compared to that of the same day standard of care clinical&#xD;
      imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 28, 2019</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of hydrocephalus</measure>
    <time_frame>Through study completion, an average of 60 minutes</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative ventricular volumes</measure>
    <time_frame>Through study completion, an average of 60 minutes</time_frame>
    <description>Quantitative ventricular volumes (mL) will be obtained and compared for low-field and companion standard clinical MRI scans.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of other important imaging findings</measure>
    <time_frame>Through study completion, an average of 60 minutes</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hydrocephalus</condition>
  <condition>Neurological Disorder</condition>
  <arm_group>
    <arm_group_label>Outpatients with known or suspected hydrocephalus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatients with other known or suspected neurological condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hyperfine MRI scan</intervention_name>
    <description>Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan.</description>
    <arm_group_label>Outpatients with known or suspected hydrocephalus</arm_group_label>
    <arm_group_label>Outpatients with other known or suspected neurological condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Suspected or confirmed diagnosis of hydrocephalus from Penn referring physician&#xD;
&#xD;
          -  Other suspected or confirmed neurological disorder from Penn referring physician&#xD;
&#xD;
          -  Routine clinical CT or MRI of the brain scheduled/obtained on the same day as&#xD;
             Hyperfine imaging.&#xD;
&#xD;
          -  Informed consent obtained from patient or legally authorized representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to routine 1.5T MRI evaluation, including electrical implants such&#xD;
             as cardiac pacemakers or perfusion pumps, ferromagnetic implants such as aneurysm&#xD;
             clips, surgical clips, protheses, artificial hearts or heart valves with steel parts,&#xD;
             metal fragments, shrapnel, tattoos near the eye, steel implants, or other irremovable&#xD;
             ferromagnetic objects&#xD;
&#xD;
          -  History of uncontrolled seizures&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Weight greater than or equal to 400lbs (181.4kg)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability or suspected inability to comply with the study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marisa Sanchez</last_name>
    <phone>215-901-9994</phone>
    <email>Marisa.Sanchez@pennmedicine.upenn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa Desiderio</last_name>
    <phone>610-721-3365</phone>
    <email>lisa.desiderio@pennmedicine.upenn.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Desiderio</last_name>
      <phone>610-721-3365</phone>
      <email>lisa.desiderio@pennmedicine.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Joel Stein</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Joel M. Stein, MD, PhD</investigator_full_name>
    <investigator_title>Assistant Professor of Radiology</investigator_title>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>CT</keyword>
  <keyword>Shunt</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04436068
org study id: 832913
nct id: NCT04436068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Presence of hydrocephalus
time frame: Through study completion, an average of 60 minutes
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.
measure: Quantitative ventricular volumes
time frame: Through study completion, an average of 60 minutes
description: Quantitative ventricular volumes (mL) will be obtained and compared for low-field and companion standard clinical MRI scans.
measure: Presence of other important imaging findings
time frame: Through study completion, an average of 60 minutes
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.
arm group label: Outpatients with known or suspected hydrocephalus
arm group type: Experimental
arm group label: Outpatients with other known or suspected neurological condition
arm group type: Experimental
intervention type: Device
intervention name: Hyperfine MRI scan
description: Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan.
arm group label: Outpatients with known or suspected hydrocephalus
arm group label: Outpatients with other known or suspected neurological condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marisa Sanchez
phone: 215-901-9994
email: Marisa.Sanchez@pennmedicine.upenn.edu
last name: Lisa Desiderio
phone: 610-721-3365
email: lisa.desiderio@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Joel M. Stein, MD, PhD
investigator title: Assistant Professor of Radiology
mesh term: Hydrocephalus
mesh term: Nervous System Diseases
sharing ipd: No