<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/NCT01674582</url>
  </required_header>
  <id_info>
    <org_study_id>Version1.0</org_study_id>
    <nct_id>NCT01674582</nct_id>
  </id_info>
  <brief_title>Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters</brief_title>
  <official_title>Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purposes with this trial is to investigate the potential of MRI with diffusion and&#xD;
      blood volume, flow in brain to diagnose and to measure treatment effects in patients with&#xD;
      intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate&#xD;
      the possibilities to individually adjusted treatment in this category of patients depending&#xD;
      on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI&#xD;
      to evaluate a correlation and to perform testing of cognitive ability before, during, and&#xD;
      after treatment and to investigate if given treatment causes any decrease in the patients&#xD;
      habitual state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</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>Early prediction of treatment response based on MRI parameters.</measure>
    <time_frame>Three weeks compared to baseline.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological function.</measure>
    <time_frame>Month 3, 12, and 18 compared to baseline</time_frame>
    <description>Neuropsychological testing to evaluate the correlation between MRI results and neuropsychological status in participating patients. This applies for 80 patients of 150 of the patient population.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Intracranial Tumor</condition>
  <arm_group>
    <arm_group_label>MRI, Neuropsychological testing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI, neuropsychological evaluation, blood sampling</intervention_name>
    <description>MRI at timepoints given above, neuropsychological testing after surgery, but before radiotherapy or chemotherapy.&#xD;
Neuropsychological testing month 3 during treatment. Neuropsychological testing after 1 year. Neuropsychological testing after 2 years.</description>
    <arm_group_label>MRI, Neuropsychological testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Suspected primary brain tumor, verified glioblastoma or non surgically treated&#xD;
             metastases from solid tumor&#xD;
&#xD;
          -  Increasing MRI changes in patients with previous verified glioblastoma&#xD;
&#xD;
          -  Be able to speak Swedish without difficulties (because of the neuropsychological&#xD;
             investigations)&#xD;
&#xD;
          -  Written informed concent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unability to perform MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pia Maly Sundgren, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skåne University Hospital Lund</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lund University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glioma</keyword>
  <keyword>Brain tumors</keyword>
  <keyword>Brain metastases</keyword>
  <keyword>MRI</keyword>
  <keyword>Cognitive measurement</keyword>
  <keyword>Neuropsychological evaluation</keyword>
  <keyword>DW-MRI</keyword>
  <keyword>P-MRI</keyword>
  <keyword>MRS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</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/NCT01674582
org study id: Version1.0
nct id: NCT01674582
lead sponsor: 
has dmc: No
The main purposes with this trial is to investigate the potential of MRI with diffusion and
      blood volume, flow in brain to diagnose and to measure treatment effects in patients with
      intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate
      the possibilities to individually adjusted treatment in this category of patients depending
      on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI
      to evaluate a correlation and to perform testing of cognitive ability before, during, and
      after treatment and to investigate if given treatment causes any decrease in the patients
      habitual state.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Early prediction of treatment response based on MRI parameters.
time frame: Three weeks compared to baseline.
measure: Neuropsychological function.
time frame: Month 3, 12, and 18 compared to baseline
description: Neuropsychological testing to evaluate the correlation between MRI results and neuropsychological status in participating patients. This applies for 80 patients of 150 of the patient population.
arm group label: MRI, Neuropsychological testing
arm group type: Other
intervention type: Other
intervention name: MRI, neuropsychological evaluation, blood sampling
description: MRI at timepoints given above, neuropsychological testing after surgery, but before radiotherapy or chemotherapy.
Neuropsychological testing month 3 during treatment. Neuropsychological testing after 1 year. Neuropsychological testing after 2 years.
arm group label: MRI, Neuropsychological testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pia Maly Sundgren, MD. PhD
role: Principal Investigator
affiliation: Skåne University Hospital Lund
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Brain Neoplasms