<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/NCT03007771</url>
  </required_header>
  <id_info>
    <org_study_id>201612155</org_study_id>
    <nct_id>NCT03007771</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia</brief_title>
  <official_title>A Feasibility Study of Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia in Human Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will help to elucidate the treatment sites in the extremities and pelvis for which&#xD;
      MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients&#xD;
      with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The&#xD;
      investigators anticipate that successful completion of this study will lead to clinical&#xD;
      trials in those feasible sites of interest to determine the safety and efficacy of&#xD;
      administering therapeutic levels of heat for hyperthermia or other applications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Decision was made to not go forward with the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 30, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2018</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the MR-HIFU device as measured by whether an area can be heated to the designated temperature and held at that temperature for an appropriate time frame</measure>
    <time_frame>1 day (2 hour timeframe)</time_frame>
    <description>-Temperature in the participant will be monitored using MR thermometry with the MR scanner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the MR-HIFU device as measured by whether an area can be heated while simultaneously maintaining patient comfort</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Patient comfort will be measured by the Comfort Score. Before the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration. After the scan, the same questions will be asked again of the subject.&#xD;
Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness). Participants will be asked to score pain/discomfort on a scale of 1-10, with 1 being minimal/none and 10 being extreme.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the MR-HIFU device as measured by whether coupling can be maintained with the body area in the same position while having contact with the transducer for an appropriate time frame.</measure>
    <time_frame>1 day (2 hour timeframe)</time_frame>
    <description>-Patients' skin will be cooled using the MR-HIFU system's direct skin cooling device to minimize over heating of the skin, unless one or more gel pads are required to achieve proper coupling to the HIFU system. In order to ensure good contact with the surface of the HIFU interface, participants may be shaved or have other hair-removal products applied to limited regions of their body.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavior of hyperthermia delivery as measured by the build-up of time until the different treatment cells can reach a desired uniform temperature</measure>
    <time_frame>1 day (2 hour time frame)</time_frame>
    <description>--Temperature in the participant will be monitored using MR thermometry with the MR scanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior of hyperthermia delivery as measured by if the heating cell behavior is the same in healthy and tumor tissues</measure>
    <time_frame>1 day (2 hour time frame)</time_frame>
    <description>--Temperature in the participant will be monitored using MR thermometry with the MR scanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior of hyperthermia delivery as measured by post-treatment heat diffusion behavior to anticipate any issues when heat is given at a clinically relevant level</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>-Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Participants</condition>
  <condition>Pelvic Neoplasms</condition>
  <condition>Soft-tissue Sarcoma</condition>
  <condition>Bladder Cancer</condition>
  <condition>Cervical Cancer</condition>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>MR-HIFU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Philips 1.5T MRI scanner equipped with a Sonalleve V2 HIFU system will be used&#xD;
Will be scanned in the MRI in 1 or more positions to the extremities and/or pelvis while aligned to the HIFU system. The HIFU device will then be used to apply sub-clinical levels (≤ 41°C) of heat to one or more small volumes. Regions will be heated to the desired temperature for variable short durations of time not exceeding 30 minutes.&#xD;
After the session is complete, the patient will be removed from the MR-HIFU system and, following a 15-30-minute period of monitoring for any adverse events, allowed to leave.&#xD;
Before the scan, after the scan and 5-10 days following the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic Resonance-guided High-Intensity Focused Ultrasound</intervention_name>
    <description>-Heating will not be performed in two areas of the body near each other (for example, not heating in two different places of the same thigh) to minimize the risk of overheating any one part of the subject's body. Heating a second target site is not mandatory, even if time allows, and the participant may refuse.</description>
    <arm_group_label>MR-HIFU</arm_group_label>
    <other_name>MR-HIFU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Patients only: must have a tumor in extremity muscle tissue or in the pelvis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of&#xD;
             metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia)&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Altman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Pelvic Neoplasms</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03007771
org study id: 201612155
nct id: NCT03007771
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study will help to elucidate the treatment sites in the extremities and pelvis for which
      MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients
      with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The
      investigators anticipate that successful completion of this study will lead to clinical
      trials in those feasible sites of interest to determine the safety and efficacy of
      administering therapeutic levels of heat for hyperthermia or other applications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Feasibility of the MR-HIFU device as measured by whether an area can be heated to the designated temperature and held at that temperature for an appropriate time frame
time frame: 1 day (2 hour timeframe)
description: -Temperature in the participant will be monitored using MR thermometry with the MR scanner
measure: Feasibility of the MR-HIFU device as measured by whether an area can be heated while simultaneously maintaining patient comfort
time frame: Up to 10 days
description: Patient comfort will be measured by the Comfort Score. Before the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration. After the scan, the same questions will be asked again of the subject.
Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness). Participants will be asked to score pain/discomfort on a scale of 1-10, with 1 being minimal/none and 10 being extreme.
measure: Feasibility of the MR-HIFU device as measured by whether coupling can be maintained with the body area in the same position while having contact with the transducer for an appropriate time frame.
time frame: 1 day (2 hour timeframe)
description: -Patients' skin will be cooled using the MR-HIFU system's direct skin cooling device to minimize over heating of the skin, unless one or more gel pads are required to achieve proper coupling to the HIFU system. In order to ensure good contact with the surface of the HIFU interface, participants may be shaved or have other hair-removal products applied to limited regions of their body.
measure: Behavior of hyperthermia delivery as measured by the build-up of time until the different treatment cells can reach a desired uniform temperature
time frame: 1 day (2 hour time frame)
description: --Temperature in the participant will be monitored using MR thermometry with the MR scanner
measure: Behavior of hyperthermia delivery as measured by if the heating cell behavior is the same in healthy and tumor tissues
time frame: 1 day (2 hour time frame)
description: --Temperature in the participant will be monitored using MR thermometry with the MR scanner
measure: Behavior of hyperthermia delivery as measured by post-treatment heat diffusion behavior to anticipate any issues when heat is given at a clinically relevant level
time frame: Up to 10 days
description: -Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness).
arm group label: MR-HIFU
arm group type: Experimental
description: Philips 1.5T MRI scanner equipped with a Sonalleve V2 HIFU system will be used
Will be scanned in the MRI in 1 or more positions to the extremities and/or pelvis while aligned to the HIFU system. The HIFU device will then be used to apply sub-clinical levels (≤ 41°C) of heat to one or more small volumes. Regions will be heated to the desired temperature for variable short durations of time not exceeding 30 minutes.
After the session is complete, the patient will be removed from the MR-HIFU system and, following a 15-30-minute period of monitoring for any adverse events, allowed to leave.
Before the scan, after the scan and 5-10 days following the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration.
intervention type: Device
intervention name: Magnetic Resonance-guided High-Intensity Focused Ultrasound
description: -Heating will not be performed in two areas of the body near each other (for example, not heating in two different places of the same thigh) to minimize the risk of overheating any one part of the subject's body. Heating a second target site is not mandatory, even if time allows, and the participant may refuse.
arm group label: MR-HIFU
other name: MR-HIFU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Altman, Ph.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Pelvic Neoplasms
mesh term: Hyperthermia
sharing ipd: No