<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/NCT03771625</url>
  </required_header>
  <id_info>
    <org_study_id>2018-GEMF-1073</org_study_id>
    <nct_id>NCT03771625</nct_id>
  </id_info>
  <brief_title>Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors</brief_title>
  <official_title>Evaluating Changes of Brain Networks and White Matter Fibers by fMRI and DTI After Treatments in Patients With Germ Cell Tumors in the Basal Ganglia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Neurosurgical Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Neurosurgical Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      BOLD-fMRI and DTI scans are performed to patients with germ cell tumors in the basal ganglia&#xD;
      before and after treatments. The changes of the MRI and muscle strength of patients during&#xD;
      treatments are evaluated, and the association between these two are investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary intracranial germ cell tumors are a specific entity of brain tumors with a variety of&#xD;
      histological types and different degrees of malignancy. Intracranial GCTs make up 11.2% -&#xD;
      15.3% of primary intracranial tumors in Asian children compared with 3.6% in the US. And&#xD;
      tumors located at the basal ganglia is much rarer.&#xD;
&#xD;
      The investigators realize that most of patients with tumors at this location are involved&#xD;
      with motor disfunction. And after treatments, some patients get relieved dramatically, but&#xD;
      some others failed to get similar outcomes. To better understand the mechanism causing this&#xD;
      difference of treatment outcomes, the investigators perform BOLD-fMRI and DTI scans to&#xD;
      patients with germ cell tumors in the basal ganglia before and after treatments. The changes&#xD;
      of the fMRI and muscle strength of patients during treatments are evaluated, and the&#xD;
      association between these two are investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Changes of brain networks measured by BOLD-fMRI after treatments.</measure>
    <time_frame>The fMRI scans are performed: (1) before treatments in one week, (2) before radiotherapy in one week, (3) after radiotherapy in one week, (4) one year after radiotherapy.</time_frame>
    <description>The brain networks during treatments are compared by functional connectivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of white matter fibers measured by DTI after treatments.</measure>
    <time_frame>The DTI scans are performed along with the fMRI scans.</time_frame>
    <description>The white matter fibers damaged by tumor are evaluated by FA and MD value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of muscle strength after treatments.</measure>
    <time_frame>The muscle strength evaluation are performed at the same day before the fMRI scans.</time_frame>
    <description>The limb muscle strength of patients are evaluated with the Medical Research Council (MRC) scale for muscle strength (grade 0-5).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Intracranial Germ Cell Tumor</condition>
  <arm_group>
    <arm_group_label>single-group studies</arm_group_label>
    <description>All the patients received chemotherapy and radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiotherapy</intervention_name>
    <description>whole brain with/without spinal cord</description>
    <arm_group_label>single-group studies</arm_group_label>
    <other_name>chemotherapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with intracranial germ cell tumor located at the basal ganglia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥3 years;&#xD;
&#xD;
          2. no history of brain radiotherapy;&#xD;
&#xD;
          3. no other known cause of movement and cognitive impairment;&#xD;
&#xD;
          4. no contraindications to the magnetic resonance imaging (MRI) scan;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients can not tolerate MR scan;&#xD;
&#xD;
          2. head motion is greater than 3 mm during functional MRI scanning.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiaoguang Qiu, M.D.</last_name>
    <phone>010-67021832</phone>
    <email>ttyy6611@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shuai Liu, M.D.</last_name>
    <phone>010-67021832</phone>
    <email>liushuai9@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuai Liu, M.D.</last_name>
      <phone>+861059975266</phone>
      <email>liushuai9@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Liang SY, Yang TF, Chen YW, Liang ML, Chen HH, Chang KP, Shan IK, Chen YS, Wong TT. Neuropsychological functions and quality of life in survived patients with intracranial germ cell tumors after treatment. Neuro Oncol. 2013 Nov;15(11):1543-51. doi: 10.1093/neuonc/not127. Epub 2013 Oct 6.</citation>
    <PMID>24101738</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fMRI</keyword>
  <keyword>DTI</keyword>
  <keyword>Intracranial Germ cell tumor</keyword>
  <keyword>Basal ganglia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Germ Cell and Embryonal</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/NCT03771625
org study id: 2018-GEMF-1073
nct id: NCT03771625
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
BOLD-fMRI and DTI scans are performed to patients with germ cell tumors in the basal ganglia
      before and after treatments. The changes of the MRI and muscle strength of patients during
      treatments are evaluated, and the association between these two are investigated.
Primary intracranial germ cell tumors are a specific entity of brain tumors with a variety of
      histological types and different degrees of malignancy. Intracranial GCTs make up 11.2% -
      15.3% of primary intracranial tumors in Asian children compared with 3.6% in the US. And
      tumors located at the basal ganglia is much rarer.

      The investigators realize that most of patients with tumors at this location are involved
      with motor disfunction. And after treatments, some patients get relieved dramatically, but
      some others failed to get similar outcomes. To better understand the mechanism causing this
      difference of treatment outcomes, the investigators perform BOLD-fMRI and DTI scans to
      patients with germ cell tumors in the basal ganglia before and after treatments. The changes
      of the fMRI and muscle strength of patients during treatments are evaluated, and the
      association between these two are investigated.
observational model: Cohort
time perspective: Prospective
measure: Changes of brain networks measured by BOLD-fMRI after treatments.
time frame: The fMRI scans are performed: (1) before treatments in one week, (2) before radiotherapy in one week, (3) after radiotherapy in one week, (4) one year after radiotherapy.
description: The brain networks during treatments are compared by functional connectivity.
measure: Changes of white matter fibers measured by DTI after treatments.
time frame: The DTI scans are performed along with the fMRI scans.
description: The white matter fibers damaged by tumor are evaluated by FA and MD value.
measure: Changes of muscle strength after treatments.
time frame: The muscle strength evaluation are performed at the same day before the fMRI scans.
description: The limb muscle strength of patients are evaluated with the Medical Research Council (MRC) scale for muscle strength (grade 0-5).
arm group label: single-group studies
description: All the patients received chemotherapy and radiotherapy.
intervention type: Radiation
intervention name: radiotherapy
description: whole brain with/without spinal cord
arm group label: single-group studies
other name: chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Xiaoguang Qiu, M.D.
phone: 010-67021832
email: ttyy6611@sina.com
last name: Shuai Liu, M.D.
phone: 010-67021832
email: liushuai9@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Liang SY, Yang TF, Chen YW, Liang ML, Chen HH, Chang KP, Shan IK, Chen YS, Wong TT. Neuropsychological functions and quality of life in survived patients with intracranial germ cell tumors after treatment. Neuro Oncol. 2013 Nov;15(11):1543-51. doi: 10.1093/neuonc/not127. Epub 2013 Oct 6.
PMID: 24101738
responsible party type: Sponsor
mesh term: Neoplasms, Germ Cell and Embryonal