xml: <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/NCT05996653</url>
    </required_header>
    <id_info>
      <org_study_id>5396</org_study_id>
      <nct_id>NCT05996653</nct_id>
    </id_info>
    <brief_title>CEST in Low-grade Glioma Study</brief_title>
    <official_title>A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sunnybrook Health Sciences Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sunnybrook Health Sciences Centre</source>
    <oversight_info>
      <has_dmc>No</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>
        Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that&#xD;
        typically present in the younger population. This project proposes to use non-contrast&#xD;
        metabolic &quot;Saturation Transfer&quot; (ST)-MRI to evaluate LGG tumour progression and aims to&#xD;
        predict early changes in LGG. Early identification of LGG patients whose tumours will&#xD;
        progress will permit early interventions. ST-MRI does not involve any intravenous injection&#xD;
        of contrast and which acquires metabolic information not seen by standard MRI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Please see trial details below:&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 12, 2022</start_date>
    <completion_date type="Anticipated">August 12, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 12, 2028</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>The time-to-progression as measured by Saturation Transfer (ST)-MRI (based on a change in volume or parameter value of over 10%) relative to the time-to-progression as measured by standard MRI using RANO-LGG.</measure>
      <time_frame>Up to 6 years, from date of initial (ST)-MRI scan until the date of progression</time_frame>
      <description>Time-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%).</measure>
      <time_frame>Up to 6 years, from date of initial (ST)-MRI scan until the date of progression</time_frame>
      <description>The accuracy will be measured based on Saturation Transfer (ST)-MRI alone without standard MRI.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Low-grade Glioma</condition>
    <arm_group>
      <arm_group_label>ST-MRI scans</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Saturation Transfer (ST)-MRI</intervention_name>
      <description>Non-contrast magnetic resonance imaging &quot;Saturation Transfer&quot; scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)</description>
      <arm_group_label>ST-MRI scans</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Be at least 12 years of age;&#xD;
  &#xD;
            2. Diagnosed with:&#xD;
  &#xD;
                 1. Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based&#xD;
                    on any combination of histological, molecular, radiological, and/or clinical&#xD;
                    findings; or&#xD;
  &#xD;
                 2. Cohort B (post-surgical): IDH1/2-mutant or IDH-wildtype (WT) low-grade glioma&#xD;
                    candidate for observation&#xD;
  &#xD;
            3. No contraindications to MRI;&#xD;
  &#xD;
            4. eGFR &gt; 30 ml/min;&#xD;
  &#xD;
            5. No prior chemotherapy or radiation therapy;&#xD;
  &#xD;
            6. No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy)&#xD;
  &#xD;
            7. Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Need for upfront post-surgical treatment with either chemotherapy and/or radiation&#xD;
               therapy&#xD;
  &#xD;
            2. Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Greg J Stanisz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sunnybrook Health Sciences Centre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mary Jane Lim-Fat, MD</last_name>
      <phone>416-480-6100</phone>
      <phone_ext>61960</phone_ext>
      <email>MaryJane.LimFat@sunnybrook.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Arjun Sahgal, MD</last_name>
      <phone>(416) 480-4998</phone>
      <email>Arjun.Sahgal@sunnybrook.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sunnybrook Health Sciences Centre</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M4N3M5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mary Jane MaryJane.LimFat@sunnybrook.ca, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>St. Michael's Hospital</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5B 1W8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sunit Das, MD, PhD</last_name>
        <phone>(416) 864-5548</phone>
        <email>sunit.das@utoronto.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
      <investigator_full_name>Dr. MaryJane Lim Fat</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996653
  org study id: 5396
  nct id: NCT05996653
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that
        typically present in the younger population. This project proposes to use non-contrast
        metabolic "Saturation Transfer" (ST)-MRI to evaluate LGG tumour progression and aims to
        predict early changes in LGG. Early identification of LGG patients whose tumours will
        progress will permit early interventions. ST-MRI does not involve any intravenous injection
        of contrast and which acquires metabolic information not seen by standard MRI.
  Please see trial details below:
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: The time-to-progression as measured by Saturation Transfer (ST)-MRI (based on a change in volume or parameter value of over 10%) relative to the time-to-progression as measured by standard MRI using RANO-LGG.
  time frame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression
  description: Time-to-progression refers to clinical progression of a low-grade glioma to a higher tumour grade.
  measure: Accuracy of Saturation Transfer (ST)-MRI for detecting progression (based on a change in volume or parameter value of over 10%).
  time frame: Up to 6 years, from date of initial (ST)-MRI scan until the date of progression
  description: The accuracy will be measured based on Saturation Transfer (ST)-MRI alone without standard MRI.
  arm group label: ST-MRI scans
  arm group type: Other
  description: All patients will undergo Saturation Transfer (ST)-MRI during their standard of care imaging visits (or within 14 days of their standard MRI).
  intervention type: Diagnostic Test
  intervention name: Saturation Transfer (ST)-MRI
  description: Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
  arm group label: ST-MRI scans
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Greg J Stanisz, PhD
  role: Principal Investigator
  affiliation: Sunnybrook Health Sciences Centre
  last name: Mary Jane Lim-Fat, MD
  phone: 416-480-6100
  phone ext: 61960
  email: MaryJane.LimFat@sunnybrook.ca
  last name: Arjun Sahgal, MD
  phone: (416) 480-4998
  email: Arjun.Sahgal@sunnybrook.ca
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Sunnybrook Health Sciences Centre
  investigator full name: Dr. MaryJane Lim Fat
  investigator title: Principal Investigator
  mesh term: Glioma