<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/NCT03806751</url>
  </required_header>
  <id_info>
    <org_study_id>R18-010</org_study_id>
    <nct_id>NCT03806751</nct_id>
  </id_info>
  <brief_title>A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning</brief_title>
  <acronym>O-15 Water</acronym>
  <official_title>A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of this project is to implement a non-invasive method of measuring&#xD;
      quantitative regional cerebral blood flow (rCBF) on the UAB hybrid PET/MRI scanner to allow&#xD;
      conducting such [O-15]water based scans with relative ease and safety in a large variety of&#xD;
      important clinical and research applications. Participants will undergo imaging at baseline&#xD;
      and after administration of a drug to increase cerebral blood flow to evaluate perfusion&#xD;
      estimates during low and high flow states. The goal of this study is to generate data that&#xD;
      will justify eliminating invasive arterial sampling in most [O-15]water-based PET protocols.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 1, 2025</start_date>
  <completion_date type="Anticipated">February 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2027</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Healthy volunteers</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI</measure>
    <time_frame>3 years</time_frame>
    <description>Measurements of regional cerebral blood flow with [O-15]water-PET/MRI using arterial sampling versus non-invasive image-based input function estimates will be compared.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging</condition>
  <arm_group>
    <arm_group_label>[O-15]water PET/MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will have two brain PET/MRI scans; first scan after injection of [O-15]water; second scan after injection of 1 gram of acetazolamide followed by injection of [O-15]water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[O-15]Water</intervention_name>
    <description>All study participants with undergo brain imaging with [O-15]water-PET/MRI without and with administration of the carbonic anhydrase inhibitor acetazolamide. The PET tracer will be used to measure regional cerebral perfusion, and the administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.</description>
    <arm_group_label>[O-15]water PET/MRI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetazolamide</intervention_name>
    <description>The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.</description>
    <arm_group_label>[O-15]water PET/MRI</arm_group_label>
    <other_name>Diamox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Six participants aged 19-60 years of age, male and female, with no evidence of&#xD;
             neurological disease, will be recruited from UAB and the surrounding community.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if there is any evidence or history of claustrophobia or&#xD;
             the subject has metallic implants or devices that are normally exclusion factors for&#xD;
             MRI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jonathan McConathy, MD, PhD</last_name>
    <phone>205-934-6504</phone>
    <email>jmcconathy@uabmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>April Riddle, RT</last_name>
    <phone>205-934-6504</phone>
    <email>ariddle@uabmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Kirklin Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UAB Advanced Imaging Facility</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Jonathan E McConathy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetazolamide</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03806751
org study id: R18-010
nct id: NCT03806751
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The overall aim of this project is to implement a non-invasive method of measuring
      quantitative regional cerebral blood flow (rCBF) on the UAB hybrid PET/MRI scanner to allow
      conducting such [O-15]water based scans with relative ease and safety in a large variety of
      important clinical and research applications. Participants will undergo imaging at baseline
      and after administration of a drug to increase cerebral blood flow to evaluate perfusion
      estimates during low and high flow states. The goal of this study is to generate data that
      will justify eliminating invasive arterial sampling in most [O-15]water-based PET protocols.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Healthy volunteers
primary purpose: Basic Science
masking: None (Open Label)
measure: Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI
time frame: 3 years
description: Measurements of regional cerebral blood flow with [O-15]water-PET/MRI using arterial sampling versus non-invasive image-based input function estimates will be compared.
arm group label: [O-15]water PET/MRI
arm group type: Experimental
description: Volunteers will have two brain PET/MRI scans; first scan after injection of [O-15]water; second scan after injection of 1 gram of acetazolamide followed by injection of [O-15]water.
intervention type: Drug
intervention name: [O-15]Water
description: All study participants with undergo brain imaging with [O-15]water-PET/MRI without and with administration of the carbonic anhydrase inhibitor acetazolamide. The PET tracer will be used to measure regional cerebral perfusion, and the administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.
arm group label: [O-15]water PET/MRI
intervention type: Drug
intervention name: Acetazolamide
description: The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.
arm group label: [O-15]water PET/MRI
other name: Diamox
criteria: 
gender: All
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan McConathy, MD, PhD
phone: 205-934-6504
email: jmcconathy@uabmc.edu
last name: April Riddle, RT
phone: 205-934-6504
email: ariddle@uabmc.edu
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Jonathan E McConathy
investigator title: Principal Investigator
mesh term: Acetazolamide