<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/NCT03265431</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002123</org_study_id>
    <nct_id>NCT03265431</nct_id>
  </id_info>
  <brief_title>Evaluation of PET/MR in Patients Selected for Ablation Therapy</brief_title>
  <official_title>Evaluation of PET/MR in Patients Selected for Ablation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is performed to assess if PET-MR imaging can improve treatment of patients with&#xD;
      irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too&#xD;
      weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One&#xD;
      category of irregular heart rate is called ventricular arrhythmia. It is often seen in&#xD;
      patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause&#xD;
      sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the&#xD;
      source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation&#xD;
      does not fix the problem in 100% of patients and some will still have the arrhythmia&#xD;
      requiring repeated procedure. The purpose of this study is to find new ways of guiding the&#xD;
      doctors performing ablation, hoping to improve the success rate of the procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2027</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TPP imaging in Ventricular Arrhythmia</measure>
    <time_frame>5 years</time_frame>
    <description>Establish imaging patterns allowing prediction of VT ablation failure</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal subjects without history of cardiac disease or arrhythmia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arrhythmia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Failure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-TPP</intervention_name>
    <description>Imaging with 18-F-TPP (18F-BFPET)</description>
    <arm_group_label>Arrhythmia</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment Failure</arm_group_label>
    <other_name>18F-BFPET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Healthy Volunteers&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be ≥21 and ≤80 years of age;&#xD;
&#xD;
          -  Subjects must provide informed consent prior to study procedures;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known structural heart disease (e.g. myocardial infarction);&#xD;
&#xD;
          -  History of ventricular arrhythmia;&#xD;
&#xD;
          -  Any contraindication to MRI and/or PET, including:&#xD;
&#xD;
          -  Subjects with life vest;&#xD;
&#xD;
          -  Subjects with implanted heart device (e.g. ICD, Pacemaker);&#xD;
&#xD;
          -  Subjects with metallic fragment or foreign body;&#xD;
&#xD;
          -  Subjects with other form of devices or prosthesis that are not MRI compatible, such as&#xD;
             insulin pump, joint replacement, hearing aid, cochlear implant, permanent&#xD;
             contraceptive devices, etc.;&#xD;
&#xD;
          -  Claustrophobia;&#xD;
&#xD;
          -  Relative or absolute contraindication to Dotarem contrast:&#xD;
&#xD;
          -  history of renal disease including acute or chronic severe renal insufficiency&#xD;
             (glomerular filtration rate &lt;60 mL/min/1.73m2);&#xD;
&#xD;
          -  a history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic&#xD;
             fibrosis, and other co-morbidities;&#xD;
&#xD;
          -  History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent&#xD;
&#xD;
          -  Any clinically significant acute or unstable physical or psychological disease, judged&#xD;
             by the investigators based on medical history or screening physical examination, to be&#xD;
             incompatible with the study;&#xD;
&#xD;
          -  Any physical or psychological disease judged by the investigators to be incompatible&#xD;
             with the study, based on medical history or screening physical examination&#xD;
&#xD;
          -  Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the&#xD;
             prior 12 months);&#xD;
&#xD;
          -  Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or&#xD;
             possibility of pregnancy cannot be ruled out prior to dosing;&#xD;
&#xD;
          -  Inability to provide written informed consent;&#xD;
&#xD;
        Arrhythmia Subjects:&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  Subjects must be ≥21 and ≤80 years of age;&#xD;
&#xD;
          -  Subjects must provide informed consent prior to study procedures;&#xD;
&#xD;
          -  History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided&#xD;
             catheter ablation for clinical care&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Any contraindication to MRI and/or PET, including:&#xD;
&#xD;
          -  Subjects with life vest;&#xD;
&#xD;
          -  Subjects with implanted heart device (e.g. ICD, Pacemaker);&#xD;
&#xD;
          -  Subjects with metallic fragment or foreign body;&#xD;
&#xD;
          -  Subjects with other form of devices or prosthesis that are not MRI compatible, such as&#xD;
             insulin pump, joint replacement, hearing aid, cochlear implant, permanent&#xD;
             contraceptive devices, etc.;&#xD;
&#xD;
          -  Claustrophobia;&#xD;
&#xD;
          -  Relative or absolute contraindication to Dotarem contrast:&#xD;
&#xD;
          -  history of renal disease including acute or chronic severe renal insufficiency&#xD;
             (glomerular filtration rate &lt;60 mL/min/1.73m2);&#xD;
&#xD;
          -  history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic&#xD;
             fibrosis, and other co-morbidities;&#xD;
&#xD;
          -  History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;Any&#xD;
             clinically significant acute or unstable physical or psychological disease, judged by&#xD;
             the investigators based on medical history or screening physical examination, to be&#xD;
             incompatible with the study;&#xD;
&#xD;
          -  Any physical or psychological disease judged by the investigators to be incompatible&#xD;
             with the study, based on medical history or screening physical examination&#xD;
&#xD;
          -  Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the&#xD;
             prior 12 months);&#xD;
&#xD;
          -  Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or&#xD;
             possibility of pregnancy cannot be ruled out prior to dosing;&#xD;
&#xD;
          -  Inability to provide written informed consent;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Macdonald-Soccorso, BS</last_name>
      <phone>617-643-1967</phone>
      <email>MMACDONALD-SOCCORSO@mgh.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>July 2, 2023</last_update_submitted>
  <last_update_submitted_qc>July 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Georges El Fakhri</investigator_full_name>
    <investigator_title>Director, Gordon Center for Medical Imaging</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT03265431
org study id: 2016P002123
nct id: NCT03265431
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is performed to assess if PET-MR imaging can improve treatment of patients with
      irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too
      weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One
      category of irregular heart rate is called ventricular arrhythmia. It is often seen in
      patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause
      sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the
      source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation
      does not fix the problem in 100% of patients and some will still have the arrhythmia
      requiring repeated procedure. The purpose of this study is to find new ways of guiding the
      doctors performing ablation, hoping to improve the success rate of the procedure.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: TPP imaging in Ventricular Arrhythmia
time frame: 5 years
description: Establish imaging patterns allowing prediction of VT ablation failure
arm group label: Control
arm group type: Active Comparator
description: Normal subjects without history of cardiac disease or arrhythmia
arm group label: Arrhythmia
arm group type: Experimental
description: This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment
arm group label: Treatment Failure
arm group type: Experimental
description: A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T
intervention type: Drug
intervention name: 18F-TPP
description: Imaging with 18-F-TPP (18F-BFPET)
arm group label: Arrhythmia
arm group label: Control
arm group label: Treatment Failure
other name: 18F-BFPET
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Georges El Fakhri
investigator title: Director, Gordon Center for Medical Imaging
mesh term: Arrhythmias, Cardiac
sharing ipd: No