<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/NCT02195154</url>
  </required_header>
  <id_info>
    <org_study_id>101-4624A</org_study_id>
    <nct_id>NCT02195154</nct_id>
  </id_info>
  <brief_title>18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism</brief_title>
  <official_title>18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism: Investigating the Correlation Between Cerebral Structural and Functional Changes, and Clinical Manifestation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the&#xD;
      study. Each evaluable subject involved in this study must fulfill all the inclusion and&#xD;
      exclusion criteria and each subject will have 3 visits in the study, as one screening visit,&#xD;
      one imaging visit, and one safety evaluation visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration is expected to be completed in a period of 3 year. The study will enroll 40&#xD;
      patients with VP and 20 healthy subjects.&#xD;
&#xD;
      This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion&#xD;
      tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task&#xD;
      functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion&#xD;
      and exclusion criteria according the subject group, each subject will have 3 visits in this&#xD;
      study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital&#xD;
      signs, physical examinations, laboratory examinations and collecting of adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <phase>Phase 2</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>The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.</measure>
    <time_frame>3 years</time_frame>
    <description>The neuroimaging parameters include the SURs of 18F-DTBZ in each brain regions, diffusion indices in each brain regions, MARS score, and activated voxels in each brain regions from the gait-related imagery task functional MRI.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The difference of diffusion indices obtained from DTI between disease and control group</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The difference of microbleed anatomical rating scale (MARS) score obtained from the SWI between disease and control group.</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The difference of functional connectivity maps associated with the seed region of interest (resting state functional MRI) between disease and control group.</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Vascular Parkinsonism</condition>
  <arm_group>
    <arm_group_label>18F-DTBZ for Vascular Parkinsonism</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject group, each subject will have 3 visits in this study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-DTBZ</intervention_name>
    <description>During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The compound is labeled with fluorine 18F that decays by positron (β+) emission and has a half life of 109.7 min. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron.&#xD;
The proposed dose for this study is based on the phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.</description>
    <arm_group_label>18F-DTBZ for Vascular Parkinsonism</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Forty patients with a diagnosis of VP whom must: i. Male or female patients; age range&#xD;
        45~80 years old. ii. Written and dated informed consent by self or by legal representative,&#xD;
        to be obtained before any of the study procedures.&#xD;
&#xD;
        iii. Patients should be fulfilled the diagnostic criteria of vascular parkinsonism&#xD;
        (Appendix I).&#xD;
&#xD;
        2. Twenty healthy subjects whom must: i. Male or female patients; age range 45~80 years&#xD;
        old. ii. Written and dated informed consent by self or by legal representative, to be&#xD;
        obtained before any of the study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at&#xD;
             screening or at any date during the study according to the PI discretion) or current&#xD;
             breast feeding.&#xD;
&#xD;
          2. Any subject who has a clinically significant abnormal laboratory values, and/or&#xD;
             clinically significant or unstable medical or psychiatric illness.&#xD;
&#xD;
             I. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine&#xD;
             disturbances.&#xD;
&#xD;
             II. Current clinically significant cardiovascular disease. (cardiac surgery or&#xD;
             myocardial infarction within the last 6 months; unstable angina; decompensated&#xD;
             congestive heart failure; significant cardiac arrhythmia; congenital heart disease.)&#xD;
&#xD;
          3. History of drug or alcohol abuse within the last year, or prior prolonged history of&#xD;
             abuse.&#xD;
&#xD;
          4. History or presence of QTc prolongation.&#xD;
&#xD;
          5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep&#xD;
             brain stimulation.&#xD;
&#xD;
          6. History of repeated head injury, hydrocephalus, encephalitis or cerebral tumors.&#xD;
&#xD;
          7. History of neurotoxin exposure&#xD;
&#xD;
          8. Any documented abnormality in the brain by CT or MRI of brain, which might contribute&#xD;
             to the motor function, such as hydrocephalus or encephalomalacia, will be excluded.&#xD;
             Cerebral vascular lesions are allowed for VP patients. Mild cortical atrophy will be&#xD;
             allowed for all subjects.&#xD;
&#xD;
          9. Patients who have neurodegenerative diseases, such as spinocerellar atrophy (SCA),&#xD;
             Wilson's disease, Parkinson's disease or Parkinson plus syndrome, are excluded.&#xD;
&#xD;
         10. General PET exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chang Gung Memory Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>February 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Wey-Yil Lin</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>18F-DTBZ</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinsonian Disorders</mesh_term>
  </condition_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/NCT02195154
org study id: 101-4624A
nct id: NCT02195154
lead sponsor: 
collaborator: 
has dmc: Yes
Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the
      study. Each evaluable subject involved in this study must fulfill all the inclusion and
      exclusion criteria and each subject will have 3 visits in the study, as one screening visit,
      one imaging visit, and one safety evaluation visit.
Study duration is expected to be completed in a period of 3 year. The study will enroll 40
      patients with VP and 20 healthy subjects.

      This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion
      tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task
      functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion
      and exclusion criteria according the subject group, each subject will have 3 visits in this
      study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital
      signs, physical examinations, laboratory examinations and collecting of adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group
time frame: 3 years
measure: The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.
time frame: 3 years
description: The neuroimaging parameters include the SURs of 18F-DTBZ in each brain regions, diffusion indices in each brain regions, MARS score, and activated voxels in each brain regions from the gait-related imagery task functional MRI.
measure: The difference of diffusion indices obtained from DTI between disease and control group
time frame: 3 years
measure: The difference of microbleed anatomical rating scale (MARS) score obtained from the SWI between disease and control group.
time frame: 3 years
measure: The difference of functional connectivity maps associated with the seed region of interest (resting state functional MRI) between disease and control group.
time frame: 3 years
arm group label: 18F-DTBZ for Vascular Parkinsonism
arm group type: Experimental
description: This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject group, each subject will have 3 visits in this study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
intervention type: Drug
intervention name: 18F-DTBZ
description: During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The compound is labeled with fluorine 18F that decays by positron (β+) emission and has a half life of 109.7 min. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron.
The proposed dose for this study is based on the phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
arm group label: 18F-DTBZ for Vascular Parkinsonism
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Wey-Yil Lin
investigator title: Instructor
mesh term: Parkinsonian Disorders