<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/NCT03031587</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/15</org_study_id>
    <nct_id>NCT03031587</nct_id>
  </id_info>
  <brief_title>Validation of Thermometric Cardiac Imaging by MRI</brief_title>
  <acronym>VAIMTH-IRM</acronym>
  <official_title>Validation of Thermometric Cardiac Imaging by MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias&#xD;
      resistant to medication. However, the absence of assessment of injury creation during&#xD;
      radiofrequency application is an important issue. One of the objectives of the Institut&#xD;
      Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is&#xD;
      to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on&#xD;
      thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time&#xD;
      visualization of tissue temperature in all the myocardium with sufficient spatial and&#xD;
      temporal resolution to characterize the induced thermal lesion. Today, investigators have&#xD;
      developed and validated a new method for cardiac thermometry, associating rapid MRI&#xD;
      acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and&#xD;
      correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic&#xD;
      field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium,&#xD;
      largely sufficient to characterize a thermal treatment induced by radiofrequency where&#xD;
      typical temperature rises of 40°C are observed during ablation. Temporal evolution of the&#xD;
      temperature in each pixel provides access to calculation of the accumulated thermal dose that&#xD;
      is a relevant indicator of the induced necrosis.&#xD;
&#xD;
      This imaging method must now be evaluated in humans in order to test its robustness under&#xD;
      real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize&#xD;
      acquisition parameters and image processing. The aim of this research is thus to obtain&#xD;
      specific MRI sequence of images of patients, on which will be evaluated the different&#xD;
      algorithms of reconstruction and processing for temperature imaging. This study is a&#xD;
      mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under&#xD;
      MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias&#xD;
      resistant to medication. However, the absence of assessment of injury creation during&#xD;
      radiofrequency application is an important issue in that it can result either in recurrences&#xD;
      of arrhythmia requiring redo procedures when an inadequate lesion is created, or on the&#xD;
      opposite in serious complications when the lesion created is too large and extents to&#xD;
      extra-cardiac territory that should be preserved. The imaging team of the IHU-Liryc develops&#xD;
      new methods in cardiac MRI in view of diagnostics (improve spatial and temporal resolution,&#xD;
      dynamic 3D imaging or contrast improvement) and therapeutics. Hence, one of the objectives of&#xD;
      the IHU-Liryc is to improve ablation procedures by radiofrequency of cardiac arrhythmias in&#xD;
      order to make them more effective (Real-time visualization of the thermal lesion, allowing&#xD;
      application of the sufficient energy needed for a transmural lesion), and safer avoiding&#xD;
      excessive lesion responsible for perforation and extension to extra-cardiac structures. This&#xD;
      is based on thermometric imaging by MRI which allows a real time visualization of tissue&#xD;
      temperature in all the myocardium with sufficient spatial and temporal resolution to&#xD;
      characterize the induced thermal lesion. MRI thermometry was developed during the last decade&#xD;
      and successfully applied clinically over a wide range of organs (the uterus, the brain, the&#xD;
      liver, the kidneys) for direct monitoring of thermal treatment of various pathologies&#xD;
      (fibroids Uterus, bone metastasis, liver cancer). This innovative technic was not applicable&#xD;
      to cardiac arrhythmias due to the respiratory and cardiac movements whose rhythms can be&#xD;
      irregular, as well as thermal noise generated by blood flow on images. Today, our team has&#xD;
      developed and preclinically validated a new rapid MRI method dedicated to cardiac&#xD;
      thermometry. All patients who give their oral agreement to participate to the study will have&#xD;
      added to their examination some acquisition sequences. The maximum additional time due to the&#xD;
      specific acquisitions of the study will be 5 minutes, over an average clinical examination&#xD;
      time of 45 minutes. No follow-up or visit of end of treatment will be performed, the end of&#xD;
      patient participation in this research corresponding to the end of the MRI examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2017</start_date>
  <completion_date type="Actual">June 13, 2019</completion_date>
  <primary_completion_date type="Actual">June 13, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calculation of the temperature variance of various measurements realized in a region of interest of the myocardium</measure>
    <time_frame>Day 0</time_frame>
    <description>1 measurement of temperature (°C) by cardiac beating</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Cardiac MRI</condition>
  <arm_group>
    <arm_group_label>MRI examination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient coming to the hospital for cardiac MRI examination can participate to the study if he/she meets the eligibility criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Additional MRI acquisition sequences</intervention_name>
    <description>It deals with specific sequences of rapid imaging acquisition in gradient echo (4 to 5 slices/cardiac cycle) with synchronization on the surface ECG systematically included in a cardiac MRI examination, together with update of the slice position depending on the respiratory state (established technique of navigator echo). The acquisition is repeated over 300 cardiac cycles to monitor myocardial temperature changes</description>
    <arm_group_label>MRI examination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>cardiac MRI</description>
    <arm_group_label>MRI examination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient requiring, as part of his/her traditional management of an MRI imaging&#xD;
             examination&#xD;
&#xD;
          -  Adults (age greater than or equal to 18 years) of both sexes&#xD;
&#xD;
          -  Minors (aged 15 to 18) of both sexes subject to the parental agreement or its legal&#xD;
             representative&#xD;
&#xD;
          -  Patient's oral agreement after reading the information note&#xD;
&#xD;
          -  Patient affiliate or beneficiary of a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 15 years of age&#xD;
&#xD;
          -  Patient unable to give oral consent&#xD;
&#xD;
          -  Patients in periods of relative exclusion in relation to another protocol&#xD;
&#xD;
          -  Patient deprived of liberty by judicial or administrative decision&#xD;
&#xD;
          -  Major protected by the law&#xD;
&#xD;
          -  Patient who does not meet the eligibility criteria for an MRI examination with or&#xD;
             without injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre JAÏS, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thermometric MRI</keyword>
  <keyword>Myocardium</keyword>
  <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/NCT03031587
org study id: CHUBX 2016/15
nct id: NCT03031587
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias
      resistant to medication. However, the absence of assessment of injury creation during
      radiofrequency application is an important issue. One of the objectives of the Institut
      Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is
      to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on
      thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time
      visualization of tissue temperature in all the myocardium with sufficient spatial and
      temporal resolution to characterize the induced thermal lesion. Today, investigators have
      developed and validated a new method for cardiac thermometry, associating rapid MRI
      acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and
      correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic
      field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium,
      largely sufficient to characterize a thermal treatment induced by radiofrequency where
      typical temperature rises of 40°C are observed during ablation. Temporal evolution of the
      temperature in each pixel provides access to calculation of the accumulated thermal dose that
      is a relevant indicator of the induced necrosis.

      This imaging method must now be evaluated in humans in order to test its robustness under
      real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize
      acquisition parameters and image processing. The aim of this research is thus to obtain
      specific MRI sequence of images of patients, on which will be evaluated the different
      algorithms of reconstruction and processing for temperature imaging. This study is a
      mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under
      MRI.
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias
      resistant to medication. However, the absence of assessment of injury creation during
      radiofrequency application is an important issue in that it can result either in recurrences
      of arrhythmia requiring redo procedures when an inadequate lesion is created, or on the
      opposite in serious complications when the lesion created is too large and extents to
      extra-cardiac territory that should be preserved. The imaging team of the IHU-Liryc develops
      new methods in cardiac MRI in view of diagnostics (improve spatial and temporal resolution,
      dynamic 3D imaging or contrast improvement) and therapeutics. Hence, one of the objectives of
      the IHU-Liryc is to improve ablation procedures by radiofrequency of cardiac arrhythmias in
      order to make them more effective (Real-time visualization of the thermal lesion, allowing
      application of the sufficient energy needed for a transmural lesion), and safer avoiding
      excessive lesion responsible for perforation and extension to extra-cardiac structures. This
      is based on thermometric imaging by MRI which allows a real time visualization of tissue
      temperature in all the myocardium with sufficient spatial and temporal resolution to
      characterize the induced thermal lesion. MRI thermometry was developed during the last decade
      and successfully applied clinically over a wide range of organs (the uterus, the brain, the
      liver, the kidneys) for direct monitoring of thermal treatment of various pathologies
      (fibroids Uterus, bone metastasis, liver cancer). This innovative technic was not applicable
      to cardiac arrhythmias due to the respiratory and cardiac movements whose rhythms can be
      irregular, as well as thermal noise generated by blood flow on images. Today, our team has
      developed and preclinically validated a new rapid MRI method dedicated to cardiac
      thermometry. All patients who give their oral agreement to participate to the study will have
      added to their examination some acquisition sequences. The maximum additional time due to the
      specific acquisitions of the study will be 5 minutes, over an average clinical examination
      time of 45 minutes. No follow-up or visit of end of treatment will be performed, the end of
      patient participation in this research corresponding to the end of the MRI examination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Calculation of the temperature variance of various measurements realized in a region of interest of the myocardium
time frame: Day 0
description: 1 measurement of temperature (°C) by cardiac beating
arm group label: MRI examination
arm group type: Experimental
description: Each patient coming to the hospital for cardiac MRI examination can participate to the study if he/she meets the eligibility criteria
intervention type: Other
intervention name: Additional MRI acquisition sequences
description: It deals with specific sequences of rapid imaging acquisition in gradient echo (4 to 5 slices/cardiac cycle) with synchronization on the surface ECG systematically included in a cardiac MRI examination, together with update of the slice position depending on the respiratory state (established technique of navigator echo). The acquisition is repeated over 300 cardiac cycles to monitor myocardial temperature changes
arm group label: MRI examination
intervention type: Device
intervention name: MRI
description: cardiac MRI
arm group label: MRI examination
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre JAÏS, MD PhD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No