<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/NCT02186262</url>
  </required_header>
  <id_info>
    <org_study_id>1234</org_study_id>
    <nct_id>NCT02186262</nct_id>
  </id_info>
  <brief_title>Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas</brief_title>
  <acronym>RODIG</acronym>
  <official_title>Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Grading of gliomas is of significant clinical importance since the prognosis as well as the&#xD;
      treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI&#xD;
      modalities, however, a reliable distinction is often impossible. Moreover, the gold standard&#xD;
      for glioma grading by histopathology may also have limitations due to unrepresentative tumor&#xD;
      samples. Therefore, more advanced MRI techniques are urgently needed that would have higher&#xD;
      sensitivity and specificity in the definition of tumor type, grade and extent.&#xD;
&#xD;
      Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria&#xD;
      12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify&#xD;
      nonresponding patients earlier, preferentially midtreatment in order to consider alternative&#xD;
      treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have&#xD;
      provided promising results in assessing early treatment response. Furthermore, a serum&#xD;
      biomarker with diagnostic value could improve tumor follow-up and clinical management of&#xD;
      gliomas.&#xD;
&#xD;
      The aim of our study is to develop novel imaging protocols suitable for the magnetic&#xD;
      resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame&#xD;
      imaging, novel DWI acquisition and post-processing methods We also study the correlation&#xD;
      between advanced MRI parameters and histopathology of the tumor specimen. In addition, early&#xD;
      treatment response is assessed with advanced MRI parameters at 3 week and 10 week after&#xD;
      initiation of radiotherapy. Finally, our objective is to study the association between serum&#xD;
      biomarkers and corresponding MRI with potential tumor progression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area</measure>
    <time_frame>Prior to surgical resection</time_frame>
    <description>Different MR relaxation parameters (T1rho-adiabatic,T1rho-cw T2rho-adiabatic,... ) and diffusion values (ADCm, ADCk, K, f, Df, Ds,...) will be measured in the tumor and surrounding area. The quantitative values will be correlated with cancer aggressiveness and tissue bio-markers. Furthermore, tumor volume will be estimated using different quantitative values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy</measure>
    <time_frame>Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy</time_frame>
    <description>Change in the different MR relaxation parameters (T1rho-adaibatic,T1rho-cw T2rho-adiabatic,... ) and diffusion values (ADCm, ADCk, K, f, Df, Ds,...) during tumor therapy will be estimated from repeated MR examinations performed before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Low Grade Glioma</condition>
  <condition>Malignant Glioma</condition>
  <arm_group>
    <arm_group_label>Primary gliomas, Recurrent gliomas</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, frozen tumor tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a brain tumor scheduled for a surgical resection at the Turku University&#xD;
        Hospital, Finland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 80 years old&#xD;
&#xD;
          -  Language spoken: Finnish or Swedish&#xD;
&#xD;
          -  Performance status: Karnofsky score 70 or better or WHO performance status 2 or better&#xD;
&#xD;
          -  Supratentorial primary malignant glioma (the diagnosis is based on radiological and&#xD;
             clinical grounds)&#xD;
&#xD;
          -  Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging&#xD;
&#xD;
          -  Patient is scheduled to either surgery or stereotactic biopsy&#xD;
&#xD;
          -  Mental status: Patients must be able to understand the meaning of the study&#xD;
&#xD;
          -  Informed consent: The patient must sign the appropriate Ethical Committee (EC)&#xD;
             approved informed consent documents in the presence of the designated staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior medical history: Patient must have no history of serious cardiovascular, liver&#xD;
             or kidney disease&#xD;
&#xD;
          -  Any psychiatric condition that compromises the subject's ability to participate in the&#xD;
             study&#xD;
&#xD;
          -  Infections: Patient must not have an uncontrolled serious infection&#xD;
&#xD;
          -  No contraindications for MRI (cardiac pacemaker, intracranial clips etc)&#xD;
&#xD;
          -  Patient must not have claustrophobia with serious symptoms&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heikki R Minn, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital, Department of Oncology and Radiotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>FI-20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Heikki Minn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Glioma</keyword>
  <keyword>MRI</keyword>
  <keyword>Rotating frame relaxation</keyword>
  <keyword>DWI</keyword>
  <keyword>treatment response</keyword>
  <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>


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/NCT02186262
org study id: 1234
nct id: NCT02186262
lead sponsor: 
has dmc: No
Grading of gliomas is of significant clinical importance since the prognosis as well as the
      treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI
      modalities, however, a reliable distinction is often impossible. Moreover, the gold standard
      for glioma grading by histopathology may also have limitations due to unrepresentative tumor
      samples. Therefore, more advanced MRI techniques are urgently needed that would have higher
      sensitivity and specificity in the definition of tumor type, grade and extent.

      Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria
      12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify
      nonresponding patients earlier, preferentially midtreatment in order to consider alternative
      treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have
      provided promising results in assessing early treatment response. Furthermore, a serum
      biomarker with diagnostic value could improve tumor follow-up and clinical management of
      gliomas.

      The aim of our study is to develop novel imaging protocols suitable for the magnetic
      resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame
      imaging, novel DWI acquisition and post-processing methods We also study the correlation
      between advanced MRI parameters and histopathology of the tumor specimen. In addition, early
      treatment response is assessed with advanced MRI parameters at 3 week and 10 week after
      initiation of radiotherapy. Finally, our objective is to study the association between serum
      biomarkers and corresponding MRI with potential tumor progression.
observational model: Case-Only
time perspective: Prospective
measure: Rotating frame relaxation and diffusion weighted MR parameters in the tumor and surrounding area
time frame: Prior to surgical resection
description: Different MR relaxation parameters (T1rho-adiabatic,T1rho-cw T2rho-adiabatic,... ) and diffusion values (ADCm, ADCk, K, f, Df, Ds,...) will be measured in the tumor and surrounding area. The quantitative values will be correlated with cancer aggressiveness and tissue bio-markers. Furthermore, tumor volume will be estimated using different quantitative values.
measure: Changes in rotating frame relaxation and diffusion weighted MR parameters in the residual tumor during therapy
time frame: Before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy
description: Change in the different MR relaxation parameters (T1rho-adaibatic,T1rho-cw T2rho-adiabatic,... ) and diffusion values (ADCm, ADCk, K, f, Df, Ds,...) during tumor therapy will be estimated from repeated MR examinations performed before, after 3 weeks, and after 10 weeks of the beginning of radiotherapy, and 12 weeks after completion of radiotherapy.
arm group label: Primary gliomas, Recurrent gliomas
Whole blood, frozen tumor tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Heikki R Minn, Professor
role: Principal Investigator
affiliation: Turku University Hospital, Department of Oncology and Radiotherapy
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Heikki Minn
investigator title: Professor
mesh term: Glioma