<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/NCT01698437</url>
  </required_header>
  <id_info>
    <org_study_id>AG2010/026,ZH 2010-0543/3</org_study_id>
    <nct_id>NCT01698437</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors</brief_title>
  <acronym>FUS-Tumor</acronym>
  <official_title>MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal&#xD;
      ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the&#xD;
      target organ. The physician then identifies a target volume in the MR images and delineates&#xD;
      the treatment contours on the images. Therapy planning software calculates the parameters&#xD;
      required to effectively treat the defined target volume. During the treatment an ultrasound&#xD;
      transducer generates and focuses ultrasound energy to a focal point, called a sonication. The&#xD;
      sonication raises the tissue temperature within a well-defined region to a degree, which&#xD;
      causes thermal coagulation. MR images acquired during sonication provide a quantitative,&#xD;
      real-time temperature map of the target area to confirm the location of the sonication and&#xD;
      the size of the coagulated region. The sonication process is repeated at multiple adjacent&#xD;
      points to cover the entire prescribed treatment volume.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lesion Size</measure>
    <time_frame>3 months</time_frame>
    <description>Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Safety</measure>
    <time_frame>3 months</time_frame>
    <description>Number of Participants with Adverse Events as a Measure of Safety and Tolerability.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Malignant Brain Tumors</condition>
  <arm_group>
    <arm_group_label>Transcranial MR-Guided Focused Ultrasound for Brain Tumors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive intervention with focused ultrasound (ExAblate 4000)</intervention_name>
    <description>Non-invasive brain intervention using MR-guided focused ultrasound</description>
    <arm_group_label>Transcranial MR-Guided Focused Ultrasound for Brain Tumors</arm_group_label>
    <other_name>ExAblate 4000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ages over 18 years old that give informed written consent to&#xD;
             participate in study. Females in reproductive age have to provide a negative serum&#xD;
             pregnancy test.&#xD;
&#xD;
          2. Patients with primary diagnosis (biopsy proven) of a malignant glioma or a recurrent&#xD;
             glioma, that do not accept a conventional tumor resection or where a conventional&#xD;
             tumor resection is not indicated according to both the neurosurgeon in charge and the&#xD;
             neuro-oncology colloquium at the Kantonsspital Aarau.&#xD;
&#xD;
             Or:&#xD;
&#xD;
             Patients with a supratentorial brain metastasis of a malignant tumor, that do not&#xD;
             accept a conventional tumor resection or where a conventional tumor resection is not&#xD;
             indicated according to the neurosurgeon in charge and the neuro-oncology colloquium at&#xD;
             the Kantonsspital Aarau.&#xD;
&#xD;
          3. The portion of the tumor to be treated during one intervention is less than 3.0 cm in&#xD;
             diameter, corresponding to a volume of ca. 14 cc.&#xD;
&#xD;
             If the total size of the tumor is larger than 3.0 cm in diameter then eventual&#xD;
             complementing ablations will not be performed before 2 week after the first treatment.&#xD;
&#xD;
          4. The tumor to be treated is clearly defined and can be well distinguished from&#xD;
             surrounding brain tissue.&#xD;
&#xD;
          5. The border of the targeted tumor volume has in all directions a distance of at least&#xD;
             2.5 cm from the inner table of the skull. Portions of the tumor that are not planned&#xD;
             to be treated due to this safety margin will be marked.&#xD;
&#xD;
          6. Patients must have an ASA score 1-2, and a Karnofsky score 70-100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All tumor Types&#xD;
&#xD;
          1. Clinical or neuroradiological signs of increased intracranial pressure.&#xD;
&#xD;
          2. Significantly increased vascularization of tumor in preoperative MR-angiogram or in&#xD;
             digital subtraction angiography (DSA).&#xD;
&#xD;
          3. Tumor mass effect that causes midline shift or a shift of the third (3rd) ventricle of&#xD;
             more than 5 mm, even after steroid therapy.&#xD;
&#xD;
          4. The border of the tumor portion to be treated is less then 5mm away from a main branch&#xD;
             of a brain vessel, the venous sinuses, the pituitary gland or the cranial nerves.&#xD;
&#xD;
          5. The tumor is in immediate proximity to a cystic formation.&#xD;
&#xD;
          6. Recent (less than 2 weeks) intracranial hemorrhage.&#xD;
&#xD;
          7. Increased risk of bleeding: platelets &lt; 100,000/mm3, INR &gt; 1.3 or other coagulation&#xD;
             disorders.&#xD;
&#xD;
          8. Tumors with presumably high risk of bleeding&#xD;
&#xD;
          9. Oral anticoagulant or thrombocyte aggregation suppression (e.g. ASS) that was not&#xD;
             stopped at least 5 days before the intervention.&#xD;
&#xD;
         10. Contraindication for MR-exams, such as non-MR-compatible implants or cardiac&#xD;
             pacemaker.&#xD;
&#xD;
         11. Clips and other implants in the sonication path or in the target area.&#xD;
&#xD;
         12. Operation implants such as dura patch, skull reconstruction with&#xD;
             polymethylmethacrylate (PalacosTM), titan in the sonication path.&#xD;
&#xD;
         13. Infratentorial (i.e. cerebellar-) tumors.&#xD;
&#xD;
         14. Contraindications for MR-contrast agents or for steroid therapy&#xD;
&#xD;
         15. Allergy against local anesthesia.&#xD;
&#xD;
         16. Uncontrolled arterial hypertension.&#xD;
&#xD;
         17. Other life threatening diseases.&#xD;
&#xD;
         18. Severe uncontrolled systemic infection.&#xD;
&#xD;
         19. Hypersensitivity to contrast agents used in this study.&#xD;
&#xD;
         20. Severely impaired renal function (estimated glomerular filtration rate &lt; 30&#xD;
             mL/min/1.73 m2) or under dialysis.&#xD;
&#xD;
         21. Inability to give informed written consent.&#xD;
&#xD;
         22. Alcohol or drug abuse.&#xD;
&#xD;
         23. Patients who are unreliable and will not appear for the follow up exams.&#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>Javier - Fandino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ernst - Martin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for MR-Research, University Children's Hospital Zurich, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MR-Center, University Children's Hospital</name>
      <address>
        <city>Zurich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>May 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>June 2, 2016</last_update_submitted>
  <last_update_submitted_qc>June 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FUS</keyword>
  <keyword>focused ultrasound</keyword>
  <keyword>functional brain disorders</keyword>
  <keyword>neuropathic pain</keyword>
  <keyword>movement disorders</keyword>
  <keyword>malignant of brain tumors</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/NCT01698437
org study id: AG2010/026,ZH 2010-0543/3
nct id: NCT01698437
lead sponsor: 
has dmc: Yes
Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal
      ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the
      target organ. The physician then identifies a target volume in the MR images and delineates
      the treatment contours on the images. Therapy planning software calculates the parameters
      required to effectively treat the defined target volume. During the treatment an ultrasound
      transducer generates and focuses ultrasound energy to a focal point, called a sonication. The
      sonication raises the tissue temperature within a well-defined region to a degree, which
      causes thermal coagulation. MR images acquired during sonication provide a quantitative,
      real-time temperature map of the target area to confirm the location of the sonication and
      the size of the coagulated region. The sonication process is repeated at multiple adjacent
      points to cover the entire prescribed treatment volume.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Lesion Size
time frame: 3 months
description: Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.
measure: Patient Safety
time frame: 3 months
description: Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
arm group label: Transcranial MR-Guided Focused Ultrasound for Brain Tumors
arm group type: Other
intervention type: Device
intervention name: Non-invasive intervention with focused ultrasound (ExAblate 4000)
description: Non-invasive brain intervention using MR-guided focused ultrasound
arm group label: Transcranial MR-Guided Focused Ultrasound for Brain Tumors
other name: ExAblate 4000
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier - Fandino, MD
role: Principal Investigator
affiliation: Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, Switzerland
last name: Ernst - Martin, MD
role: Principal Investigator
affiliation: Center for MR-Research, University Children's Hospital Zurich, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Brain Neoplasms