<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/NCT04486248</url>
  </required_header>
  <id_info>
    <org_study_id>ASL/BBRC2019</org_study_id>
    <nct_id>NCT04486248</nct_id>
  </id_info>
  <brief_title>Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion</brief_title>
  <official_title>Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this project, we aim at implementing a te-ASL sequence and to compare it to two reference&#xD;
      ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence&#xD;
      will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according&#xD;
      the Consensus of the ISMRM perfusion study group and the European consortium for ASL in&#xD;
      dementia. On the other, as the implemented te-ASL sequence will have a 2D readout, it will&#xD;
      also be compared to a 2D pCASL ASL sequence with the same PLD, in order to be able to&#xD;
      disentangle differences due to the dynamic PLD scheme from those arising from the different&#xD;
      read-out schemes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2019</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">February 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ASL perfusion MRI data</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Quantification of cerebral blood flow</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Thirty (N=30) healthy individuals older than 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To sign the study informed consent form approved by the corresponding authorities.&#xD;
&#xD;
          -  Healthy men and women (older than 18 years old).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or unwillingness to give written informed consent or communicate with the&#xD;
             study staff or illiteracy.&#xD;
&#xD;
          -  Any contraindication to perform brain MRI procedure (e.g. pacemaker, MRI-incompatible&#xD;
             aneurysm clips).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BarcelonaBeta Brain Research Center</name>
      <address>
        <city>Barcelona</city>
        <zip>08005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04486248
org study id: ASL/BBRC2019
nct id: NCT04486248
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this project, we aim at implementing a te-ASL sequence and to compare it to two reference
      ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence
      will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according
      the Consensus of the ISMRM perfusion study group and the European consortium for ASL in
      dementia. On the other, as the implemented te-ASL sequence will have a 2D readout, it will
      also be compared to a 2D pCASL ASL sequence with the same PLD, in order to be able to
      disentangle differences due to the dynamic PLD scheme from those arising from the different
      read-out schemes.
observational model: Other
time perspective: Cross-Sectional
measure: ASL perfusion MRI data
time frame: Through study completion, an average of 1 year
description: Quantification of cerebral blood flow
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
sharing ipd: Undecided