<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/NCT04451213</url>
  </required_header>
  <id_info>
    <org_study_id>19/MAR/7625</org_study_id>
    <nct_id>NCT04451213</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis</brief_title>
  <official_title>Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff and Vale University Health Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiff and Vale University Health Board</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CF is a complex, inherited illness that can affect many organs of the body. The investigators&#xD;
      have found that some patients with CF have reported more problems with memory than would be&#xD;
      expected at their age and that patients appear to be using memory strategies to overcome&#xD;
      memory loss. The investigators intend to objectively test memory and examine MRI images of&#xD;
      the brain of patients with CF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with CF have several potential risk factors which may predispose them to memory&#xD;
      problems. Because the CF population has historically only been young, this is not something&#xD;
      that has been focused on. No research has currently identified whether patients with CF have&#xD;
      a much earlier risk of developing cognitive impairment or how CF impacts on the brain.&#xD;
&#xD;
      There has not previously been work in this area of CF and the investigators are in a unique&#xD;
      position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise&#xD;
      to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on&#xD;
      patients with CF for the first time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2021</start_date>
  <completion_date type="Actual">December 23, 2022</completion_date>
  <primary_completion_date type="Actual">December 23, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective memory scores</measure>
    <time_frame>up to one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>MRI head</measure>
    <time_frame>up to one year</time_frame>
    <description>the investigators will acquire structural and functional MRI data at 3T to explore brain health of CF patients compared to control data. Structural MRI will include T1 and T2 weighted anatomical images for group comparisons of brain morphology (volume, cortical thickness). T1 weighted images will also be used as reference images for all other MRI parameters.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI head</intervention_name>
    <description>MRI head</description>
    <arm_group_label>experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female, aged greater or equal to 30 years&#xD;
&#xD;
               -  A diagnosis of CF&#xD;
&#xD;
               -  Primary school education or above&#xD;
&#xD;
               -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to MRI as found on the CUBRIC screening form (including presence of&#xD;
             indwelling metal devices/clips)&#xD;
&#xD;
               -  Existing neurological disease affecting cognition (including stroke and traumatic&#xD;
                  brain injury)&#xD;
&#xD;
               -  Existing diagnosis of dementia documented in medical notes&#xD;
&#xD;
               -  Vascular complications of diabetes&#xD;
&#xD;
               -  Requiring supplemental oxygen -long term or overnight&#xD;
&#xD;
               -  Hepatic failure&#xD;
&#xD;
               -  Overt psychiatric disorders&#xD;
&#xD;
               -  Past or present alcohol or recreational drug misuse&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Current infection Smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiff and VAle University Health Board</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT04451213
org study id: 19/MAR/7625
nct id: NCT04451213
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
CF is a complex, inherited illness that can affect many organs of the body. The investigators
      have found that some patients with CF have reported more problems with memory than would be
      expected at their age and that patients appear to be using memory strategies to overcome
      memory loss. The investigators intend to objectively test memory and examine MRI images of
      the brain of patients with CF.
Patients with CF have several potential risk factors which may predispose them to memory
      problems. Because the CF population has historically only been young, this is not something
      that has been focused on. No research has currently identified whether patients with CF have
      a much earlier risk of developing cognitive impairment or how CF impacts on the brain.

      There has not previously been work in this area of CF and the investigators are in a unique
      position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise
      to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on
      patients with CF for the first time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Objective memory scores
time frame: up to one year
measure: MRI head
time frame: up to one year
description: the investigators will acquire structural and functional MRI data at 3T to explore brain health of CF patients compared to control data. Structural MRI will include T1 and T2 weighted anatomical images for group comparisons of brain morphology (volume, cortical thickness). T1 weighted images will also be used as reference images for all other MRI parameters.
arm group label: experimental
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: MRI head
description: MRI head
arm group label: experimental
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No