<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/NCT01693770</url>
  </required_header>
  <id_info>
    <org_study_id>BM-MRgFUS</org_study_id>
    <nct_id>NCT01693770</nct_id>
  </id_info>
  <brief_title>Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound</brief_title>
  <official_title>Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for&#xD;
      pain control through thermally-induced cell death and periosteal denervation caused by&#xD;
      cortical heating relative to acoustic energy absorption. There is also evidence that a high&#xD;
      intensity focused ultrasound beam can penetrate through the cortical bone to the medullary&#xD;
      space, producing thermal necrosis of cancer tissue. However, little is known about the&#xD;
      potential effects of MRgFUS as first line therapeutic modality for pain palliation in&#xD;
      skeletal metastases.&#xD;
&#xD;
      Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of&#xD;
      painful bone metastases and determine the potential of this technique for local tumor&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the&#xD;
      failure of other therapies, our study will be conducted in patients not previously treated&#xD;
      with EBRT to the targeted lesion.&#xD;
&#xD;
      This is an important new feature, especially given the advantages of MRgFUS, such as lack of&#xD;
      ionizing radiation, the ability to conduct treatment on an outpatient basis and the&#xD;
      possibility to repeat the treatment as necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases</measure>
    <time_frame>6 months</time_frame>
    <description>Patients will be monitored for major or minor adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging</measure>
    <time_frame>6 months</time_frame>
    <description>necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Secondary Malignant Neoplasm of Bone</condition>
  <arm_group>
    <arm_group_label>MRgFUS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>High intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRgFUS</intervention_name>
    <description>Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.</description>
    <arm_group_label>MRgFUS</arm_group_label>
    <other_name>MRgFUS, ExAblate, InSightec</other_name>
    <other_name>MR-HIFU</other_name>
    <other_name>Magnetic Resonance-guided Focused Ultrasound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of a known primary cancer and bone metastases confirmed by two or more&#xD;
             imaging modalities;&#xD;
&#xD;
          -  exhaustion or refusal of all other pain palliation methods including EBRT;&#xD;
&#xD;
          -  confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination&#xD;
             (presence of an adequate acoustic window between the transducer, skin and target&#xD;
             lesion and absence of bowel loops across the planned ultrasound path)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  general contraindication to MR imaging (including pacemaker, ferromagnetic devices or&#xD;
             implants)&#xD;
&#xD;
          -  general contraindication to gadolinium-based contrast agents (intolerance and/or&#xD;
             clinically proven chronic renal failure)&#xD;
&#xD;
          -  general contraindication to general/epidural anesthesia or deep sedation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Napoli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Radiological Sciences, Sapienza University of Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <zip>00100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>June 17, 2014</last_update_submitted>
  <last_update_submitted_qc>June 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Alessandro Napoli</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Bone Metastasis</keyword>
  <keyword>Pain Palliation</keyword>
  <keyword>High Intensity Focused Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Bone 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/NCT01693770
org study id: BM-MRgFUS
nct id: NCT01693770
lead sponsor: 
has dmc: Yes
Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for
      pain control through thermally-induced cell death and periosteal denervation caused by
      cortical heating relative to acoustic energy absorption. There is also evidence that a high
      intensity focused ultrasound beam can penetrate through the cortical bone to the medullary
      space, producing thermal necrosis of cancer tissue. However, little is known about the
      potential effects of MRgFUS as first line therapeutic modality for pain palliation in
      skeletal metastases.

      Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of
      painful bone metastases and determine the potential of this technique for local tumor
      control.
Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the
      failure of other therapies, our study will be conducted in patients not previously treated
      with EBRT to the targeted lesion.

      This is an important new feature, especially given the advantages of MRgFUS, such as lack of
      ionizing radiation, the ability to conduct treatment on an outpatient basis and the
      possibility to repeat the treatment as necessary.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
time frame: 6 months
description: Patients will be monitored for major or minor adverse events
measure: To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging
time frame: 6 months
description: necrosis of the actual lesion will be analyzed according to area on non-perfused volume at the end of the procedure
arm group label: MRgFUS
arm group type: Other
description: High intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence.
intervention type: Procedure
intervention name: MRgFUS
description: Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.
arm group label: MRgFUS
other name: MRgFUS, ExAblate, InSightec
other name: MR-HIFU
other name: Magnetic Resonance-guided Focused Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Alessandro Napoli, MD, PhD
role: Principal Investigator
affiliation: Department of Radiological Sciences, Sapienza University of Rome
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Alessandro Napoli
investigator title: MD, PhD
mesh term: Neoplasm Metastasis
mesh term: Neoplasms
mesh term: Bone Neoplasms