<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/NCT01733173</url>
  </required_header>
  <id_info>
    <org_study_id>12-121</org_study_id>
    <nct_id>NCT01733173</nct_id>
  </id_info>
  <brief_title>Functional Imaging of Cerebellar Mutism Syndrome</brief_title>
  <official_title>Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to better understand why some children with cancer have&#xD;
      difficulty speaking after brain surgery. Difficulty speaking may be due to known&#xD;
      complications to the language centers in the brain. These language centers may be located in&#xD;
      slightly different places in different people. This study will study which areas may be&#xD;
      damaged.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 12, 2021</completion_date>
  <primary_completion_date type="Actual">October 12, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>investigate the feasibility of performing preoperative fMRI</measure>
    <time_frame>1 year</time_frame>
    <description>in young children at risk for developing CMS after posterior fossa brain tumor resection. Age appropriate language functional MRI tasks targeting the cerebellar language centers will be performed in children before surgery and correlated with formal neuropsychological and language testing. The fMRI will be repeated after surgery. If ≥5 of the 7 subjects successfully complete ≥60% of the functional imaging tests, we will determine the pilot study to be successful and then pursue further study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography</measure>
    <time_frame>1 year</time_frame>
    <description>in subjects who develop CMS after brain tumor resection. Injury to cerebro-cerebellar tracts such as the dentatothalamocortical tracts has been implicated in the development of CMS. We propose studying the proximity between important language white matter paths and the surgical intervention before surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the preoperative scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate potential changes in DTI after posterior fossa surgery</measure>
    <time_frame>1 year</time_frame>
    <description>that may correlate with the development of CMS. We hypothesize that measurements of water diffusion by DTI and tractography will be altered in subjects who develop CMS, even without striking anatomical changes after surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the postoperative scan. The preoperative and postoperative DTI results will be compared.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Brain Mass</condition>
  <arm_group>
    <arm_group_label>mass in posterior fossa, either benign or malignant</arm_group_label>
    <description>A pilot study will be performed. We will perform fMRI and DTI in children before and after surgery for posterior fossa brain tumors. Each subject will receive the standard of care for their brain tumors in terms of surgical resection, radiation therapy and/or chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI with DTI and fMRI</intervention_name>
    <description>When possible, the subject will undergo a post operative fMRI/ DTI scan as well as clinical language testing. If the subject develops CMS, the second fMRI will be performed as soon as possible. Some subjects may be severely impaired or have difficulty performing fMRI and clinical language testing tasks. In these instances, the fMRI and language testing may not be performed, or we may choose to perform resting state or passive fMRI tasks instead.</description>
    <arm_group_label>mass in posterior fossa, either benign or malignant</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        MSK clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject and/or guardian is able to provide written informed consent prior to study&#xD;
             registration&#xD;
&#xD;
          -  Age ≥3 years and ≤21 years&#xD;
&#xD;
          -  Newly diagnosed, untreated mass in posterior fossa, either benign or malignant&#xD;
&#xD;
          -  Is being evaluated for surgical resection of the mass&#xD;
&#xD;
          -  Able to perform clinical language testing in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).&#xD;
&#xD;
          -  Pregnant or nursing female&#xD;
&#xD;
          -  Does not speak English as a primary language (as determined by the P.I. or treating&#xD;
             physician after discussion with a potential subject and his/her family)&#xD;
&#xD;
          -  Preexisting language or developmental disorder that would limit ability to cooperate&#xD;
             with testing (as determined by the P.I. or treating physician after interviewing&#xD;
             potential subject and his/her family; for example, a child may be excluded if he/she&#xD;
             has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp,&#xD;
             hypotonia, or other age inappropriate speech development)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert J. Young, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mass in posterior fossa</keyword>
  <keyword>benign</keyword>
  <keyword>malignant</keyword>
  <keyword>surgical resection</keyword>
  <keyword>MRI</keyword>
  <keyword>fMRI</keyword>
  <keyword>DTI</keyword>
  <keyword>12-121</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mutism</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/NCT01733173
org study id: 12-121
nct id: NCT01733173
lead sponsor: 
The purpose of this study is to better understand why some children with cancer have
      difficulty speaking after brain surgery. Difficulty speaking may be due to known
      complications to the language centers in the brain. These language centers may be located in
      slightly different places in different people. This study will study which areas may be
      damaged.
observational model: Cohort
time perspective: Prospective
measure: investigate the feasibility of performing preoperative fMRI
time frame: 1 year
description: in young children at risk for developing CMS after posterior fossa brain tumor resection. Age appropriate language functional MRI tasks targeting the cerebellar language centers will be performed in children before surgery and correlated with formal neuropsychological and language testing. The fMRI will be repeated after surgery. If ≥5 of the 7 subjects successfully complete ≥60% of the functional imaging tests, we will determine the pilot study to be successful and then pursue further study.
measure: To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography
time frame: 1 year
description: in subjects who develop CMS after brain tumor resection. Injury to cerebro-cerebellar tracts such as the dentatothalamocortical tracts has been implicated in the development of CMS. We propose studying the proximity between important language white matter paths and the surgical intervention before surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the preoperative scan
measure: To investigate potential changes in DTI after posterior fossa surgery
time frame: 1 year
description: that may correlate with the development of CMS. We hypothesize that measurements of water diffusion by DTI and tractography will be altered in subjects who develop CMS, even without striking anatomical changes after surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the postoperative scan. The preoperative and postoperative DTI results will be compared.
arm group label: mass in posterior fossa, either benign or malignant
description: A pilot study will be performed. We will perform fMRI and DTI in children before and after surgery for posterior fossa brain tumors. Each subject will receive the standard of care for their brain tumors in terms of surgical resection, radiation therapy and/or chemotherapy.
intervention type: Procedure
intervention name: MRI with DTI and fMRI
description: When possible, the subject will undergo a post operative fMRI/ DTI scan as well as clinical language testing. If the subject develops CMS, the second fMRI will be performed as soon as possible. Some subjects may be severely impaired or have difficulty performing fMRI and clinical language testing tasks. In these instances, the fMRI and language testing may not be performed, or we may choose to perform resting state or passive fMRI tasks instead.
arm group label: mass in posterior fossa, either benign or malignant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 21 Years
healthy volunteers: No
last name: Robert J. Young, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Mutism