<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/NCT04463979</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105872</org_study_id>
    <nct_id>NCT04463979</nct_id>
  </id_info>
  <brief_title>Perioperative Evaluation of Cerebellar Tumors</brief_title>
  <official_title>Perioperative Evaluation of Cerebellar Tumors: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, cohort study to evaluate the impact of cerebellar functional&#xD;
      topography on perioperative outcomes related to cognition and motor ataxia in patients with&#xD;
      cerebellar tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose of the Study: This is a prospective, cohort study to evaluate the impact of&#xD;
      cerebellar functional topography on perioperative outcomes related to cognition and motor&#xD;
      ataxia in patients with cerebellar tumors.&#xD;
&#xD;
      Primary Aim: The primary aim of this study is to determine if patients with a cerebellar&#xD;
      tumor are more likely to test positive for cerebellar cognitive affective syndrome than&#xD;
      patients with non-cerebellar tumors. This information will be used to improve perioperative&#xD;
      assessment in patients with tumors of the cerebellum.&#xD;
&#xD;
      Secondary Aim: To determine the impact of tumor location and cerebellar functional topography&#xD;
      on perioperative outcomes (determined by standard of care neurological evaluation and brain&#xD;
      images) in patients undergoing resection of cerebellar tumors. This information will be used&#xD;
      to improve perioperative assessment in patients with tumors of the cerebellum.&#xD;
&#xD;
      Study Interventions: Thirty-three adult (≥18 years of age) patients with primary cerebellar&#xD;
      brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery&#xD;
      for tumor resection, and 33 adult patients with primary non-cerebellar brain tumors or&#xD;
      metastatic tumors located in a non-cerebellar brain location who will also undergo surgery&#xD;
      for tumor resection will be included in this study. The non-cerebellar brain tumor control&#xD;
      group will be included for comparison. Participants in this study will undergo surgical&#xD;
      resection of their cerebellar or brain tumor (as per standard of care), as well as clinical&#xD;
      and radiographic assessment, including: neurological physical examination (including&#xD;
      Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance&#xD;
      imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to,&#xD;
      immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical&#xD;
      resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days)&#xD;
      visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these&#xD;
      two time points. Only at baseline, the following will be conducted: Brief Ataxia Rating Scale&#xD;
      (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome)&#xD;
      scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL)&#xD;
      assessment using the SF-36 questionnaire.&#xD;
&#xD;
      Data analysis: For each test item within the CCAS there is a threshold score allowing a&#xD;
      pass/fail determination that differentiates CCAS-positive patients from CCAS-negative&#xD;
      patients. The primary, study endpoint is the percentage of patients with a positive CCAS&#xD;
      diagnosis prior to surgery. The investigators will evaluate whether CCAS is preferentially&#xD;
      seen in association with any demographic or descriptive variables (particularly tumor&#xD;
      location in the cerebellum) using chi-squared testing unless otherwise indicated. Demographic&#xD;
      data including sex, age at time of brain tumor diagnosis and at surgery, education level&#xD;
      completed, and dominant writing hand will be described. The distribution of each of the&#xD;
      following preoperative variables will also be described: presenting symptom (cognitive,&#xD;
      motor, or vestibular), brain lesion type (newly diagnosed vs recurrent), primary tumor site,&#xD;
      primary tumor histology, presence or absence of a systemic burden of disease, presence of&#xD;
      hydrocephalus or previous seizure in 30 days prior to surgery, prior surgery, prior whole&#xD;
      brain radiation or stereotactic radiosurgery, initiation of antiepileptic or steroids prior&#xD;
      to surgery, the indication for surgery. These data will be used to compare baseline&#xD;
      characteristic of cerebellar tumor patients with non-cerebellar brain tumor patients. All&#xD;
      statistical analysis will be performed by the investigators using Prism 4.0 (GraphPad&#xD;
      Software, Inc.) and Stata v10 (StataCorp Lp). Significance will be assessed at alpha = 0.05.&#xD;
&#xD;
      Risks/Benefits: There will be physical or health-related risks to the surgical resection of&#xD;
      the patients' cerebellar tumor according to the standard of care. Risk is also involved to&#xD;
      the extent that privacy and confidentiality may be compromised. However, every reasonable&#xD;
      effort will be made to limit breaches of privacy and confidentiality. Participants will not&#xD;
      benefit directly from this study. However, the results of this work will help improve the&#xD;
      perioperative assessment of patients with tumors of the cerebellum, which may improve&#xD;
      rehabilitation efforts in this unique patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 28, 2021</start_date>
  <completion_date type="Anticipated">April 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</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>Percentage of cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery</measure>
    <time_frame>Baseline</time_frame>
    <description>CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of brain non-cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery</measure>
    <time_frame>Baseline</time_frame>
    <description>CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors</measure>
    <time_frame>Discharge (1-2 days after surgery)</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors</measure>
    <time_frame>18 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors</measure>
    <time_frame>24 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors</measure>
    <time_frame>Discharge (1-2 days after surgery)</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors</measure>
    <time_frame>18 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors</measure>
    <time_frame>24 months after surgery</time_frame>
    <description>&quot;Impact&quot; will be determined with standard of care neurological evaluation and &quot;tumor location&quot; with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Cerebellar Tumors</condition>
  <condition>Brain Tumor</condition>
  <arm_group>
    <arm_group_label>Cerebellar Tumors</arm_group_label>
    <description>Thirty-three adult (≥18 years of age) patients with primary cerebellar tumors or metastatic tumors located in the cerebellum who will undergo surgery for tumor resection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brain Tumors</arm_group_label>
    <description>Thirty-three adult (≥18 years of age) patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection. This group will be included for comparison.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia</intervention_name>
    <description>Participants in this study will undergo surgical resection of their cerebellar or brain tumor (as per standard of care), as well as clinical and radiographic assessment, including: neurological physical examination (including Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these two time points.&#xD;
Only at baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment using the SF-36 questionnaire.</description>
    <arm_group_label>Brain Tumors</arm_group_label>
    <arm_group_label>Cerebellar Tumors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thirty-three adult (≥18 years of age) patients with primary cerebellar brain tumors or&#xD;
        metastatic brain tumors located in the cerebellum who will undergo surgery for tumor&#xD;
        resection, and 33 adult patients with primary non-cerebellar brain tumors or metastatic&#xD;
        tumors located in a non-cerebellar brain location who will also undergo surgery for tumor&#xD;
        resection will be included in this study. The non-cerebellar brain tumor control group will&#xD;
        be included for comparison.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Patients with primary cerebellar brain tumors or metastatic brain tumors located in&#xD;
             the cerebellum who will undergo surgery for tumor resection, OR with primary&#xD;
             non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain&#xD;
             location who will undergo surgery for tumor resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients with intracranial pathologies (e.g. stroke, vasculitis, infection,&#xD;
             developmental anomalies, etc.) outside of the cerebellum&#xD;
&#xD;
          -  Non-oncologic cerebellar pathologies (e.g. stroke, vasculitis, infection,&#xD;
             developmental anomalies, primary cerebellar ataxias, etc.)&#xD;
&#xD;
          -  Patients who are illiterate, are blind, or do not read or understand English&#xD;
&#xD;
          -  Patients with a Karnofsky Performance Status score of equal to less than 40&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allan H Friedman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eric W Sankey, M.D.</last_name>
    <phone>919-970-9408</phone>
    <email>eric.sankey@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia E Pamanes, MPH</last_name>
    <phone>919-668-0897</phone>
    <email>claudia.pamanes@duke.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric W Sankey, MD</last_name>
      <phone>919-970-9408</phone>
      <email>eric.sankey@duke.edu</email>
    </contact>
    <contact_backup>
      <last_name>Claudia E Pamanes, MPH</last_name>
      <phone>919-668-0897</phone>
      <email>claudia.pamanes@duke.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Allan H Friedman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Cerebellar Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04463979
org study id: Pro00105872
nct id: NCT04463979
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, cohort study to evaluate the impact of cerebellar functional
      topography on perioperative outcomes related to cognition and motor ataxia in patients with
      cerebellar tumors.
Purpose of the Study: This is a prospective, cohort study to evaluate the impact of
      cerebellar functional topography on perioperative outcomes related to cognition and motor
      ataxia in patients with cerebellar tumors.

      Primary Aim: The primary aim of this study is to determine if patients with a cerebellar
      tumor are more likely to test positive for cerebellar cognitive affective syndrome than
      patients with non-cerebellar tumors. This information will be used to improve perioperative
      assessment in patients with tumors of the cerebellum.

      Secondary Aim: To determine the impact of tumor location and cerebellar functional topography
      on perioperative outcomes (determined by standard of care neurological evaluation and brain
      images) in patients undergoing resection of cerebellar tumors. This information will be used
      to improve perioperative assessment in patients with tumors of the cerebellum.

      Study Interventions: Thirty-three adult (≥18 years of age) patients with primary cerebellar
      brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery
      for tumor resection, and 33 adult patients with primary non-cerebellar brain tumors or
      metastatic tumors located in a non-cerebellar brain location who will also undergo surgery
      for tumor resection will be included in this study. The non-cerebellar brain tumor control
      group will be included for comparison. Participants in this study will undergo surgical
      resection of their cerebellar or brain tumor (as per standard of care), as well as clinical
      and radiographic assessment, including: neurological physical examination (including
      Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance
      imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to,
      immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical
      resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days)
      visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these
      two time points. Only at baseline, the following will be conducted: Brief Ataxia Rating Scale
      (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome)
      scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL)
      assessment using the SF-36 questionnaire.

      Data analysis: For each test item within the CCAS there is a threshold score allowing a
      pass/fail determination that differentiates CCAS-positive patients from CCAS-negative
      patients. The primary, study endpoint is the percentage of patients with a positive CCAS
      diagnosis prior to surgery. The investigators will evaluate whether CCAS is preferentially
      seen in association with any demographic or descriptive variables (particularly tumor
      location in the cerebellum) using chi-squared testing unless otherwise indicated. Demographic
      data including sex, age at time of brain tumor diagnosis and at surgery, education level
      completed, and dominant writing hand will be described. The distribution of each of the
      following preoperative variables will also be described: presenting symptom (cognitive,
      motor, or vestibular), brain lesion type (newly diagnosed vs recurrent), primary tumor site,
      primary tumor histology, presence or absence of a systemic burden of disease, presence of
      hydrocephalus or previous seizure in 30 days prior to surgery, prior surgery, prior whole
      brain radiation or stereotactic radiosurgery, initiation of antiepileptic or steroids prior
      to surgery, the indication for surgery. These data will be used to compare baseline
      characteristic of cerebellar tumor patients with non-cerebellar brain tumor patients. All
      statistical analysis will be performed by the investigators using Prism 4.0 (GraphPad
      Software, Inc.) and Stata v10 (StataCorp Lp). Significance will be assessed at alpha = 0.05.

      Risks/Benefits: There will be physical or health-related risks to the surgical resection of
      the patients' cerebellar tumor according to the standard of care. Risk is also involved to
      the extent that privacy and confidentiality may be compromised. However, every reasonable
      effort will be made to limit breaches of privacy and confidentiality. Participants will not
      benefit directly from this study. However, the results of this work will help improve the
      perioperative assessment of patients with tumors of the cerebellum, which may improve
      rehabilitation efforts in this unique patient population.
observational model: Cohort
time perspective: Prospective
measure: Percentage of cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery
time frame: Baseline
description: CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)
measure: Percentage of brain non-cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery
time frame: Baseline
description: CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)
measure: Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors
time frame: Discharge (1-2 days after surgery)
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors
time frame: 1 month after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors
time frame: 6 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors
time frame: 12 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors
time frame: 18 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors
time frame: 24 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors
time frame: Discharge (1-2 days after surgery)
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors
time frame: 1 month after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors
time frame: 6 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors
time frame: 12 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors
time frame: 18 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
measure: Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors
time frame: 24 months after surgery
description: "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography
arm group label: Cerebellar Tumors
description: Thirty-three adult (≥18 years of age) patients with primary cerebellar tumors or metastatic tumors located in the cerebellum who will undergo surgery for tumor resection.
arm group label: Brain Tumors
description: Thirty-three adult (≥18 years of age) patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection. This group will be included for comparison.
intervention type: Other
intervention name: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia
description: Participants in this study will undergo surgical resection of their cerebellar or brain tumor (as per standard of care), as well as clinical and radiographic assessment, including: neurological physical examination (including Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these two time points.
Only at baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment using the SF-36 questionnaire.
arm group label: Brain Tumors
arm group label: Cerebellar Tumors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Allan H Friedman, MD
role: Principal Investigator
affiliation: Duke Health
last name: Eric W Sankey, M.D.
phone: 919-970-9408
email: eric.sankey@duke.edu
last name: Claudia E Pamanes, MPH
phone: 919-668-0897
email: claudia.pamanes@duke.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Cerebellar Neoplasms
sharing ipd: No