xml: <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/NCT05976711</url>
    </required_header>
    <id_info>
      <org_study_id>2008987</org_study_id>
      <nct_id>NCT05976711</nct_id>
    </id_info>
    <brief_title>New MRI Techniques for Diagnosis and Treatment of Abdominal Aortic Aneurysms</brief_title>
    <acronym>MARVY</acronym>
    <official_title>Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Brightfish</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nano4Imaging GmbH</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
        An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly&#xD;
        which can rupture leading to bleeding within the belly. To prevent rupture elective surgery&#xD;
        can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is&#xD;
        inserted into the AAA to prevent it from further growth and rupture.&#xD;
  &#xD;
        Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to&#xD;
        determine upon timing of elective repair but is unprecise in predicting the risk of rupture&#xD;
        resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurence remain&#xD;
        unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US)&#xD;
        utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly&#xD;
        exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the&#xD;
        standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced&#xD;
        MRI techniques are used to find out if standard imaging techniques could be replaced by MRI&#xD;
        in three phases of the AAA management (surveillance, surgery planning and post-operative&#xD;
        follow-up). The two most important MRI techniques that will be used are 4D flow MRI and&#xD;
        dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow&#xD;
        within the AAA and perfusion of the aortic wall.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 4, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Surveillance: correlation between growth rate and MRI derived parameters</measure>
      <time_frame>1 year</time_frame>
      <description>The main study parameter for phase B1 (surveillance) is the correlation between growth rate of the AAA (determinant for the standard of care) and measured MRI parameters acquired with 4D flow MRI and DCE-MRI.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EVAR planning: correlation between morphological parameters measured based on MRA and CTA</measure>
      <time_frame>half year</time_frame>
      <description>The main study parameter for phase B2 (EVAR planning) is the difference between anatomical measurements (lengths and diameters) based on both CTA and MRA. Several quantitative anatomical measurements will be utilised to assess the feasibility of MRA for planning of EVARs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EVAR follow up: difference in MRI parameters between patients with endoleaks and without</measure>
      <time_frame>1 year</time_frame>
      <description>The main study parameter for phase B3 (EVAR follow-up) is the difference in MRI parameters measured post-operatively in patients with and without EVAR related complications.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Abdominal Aortic Aneurysm Without Rupture</condition>
    <arm_group>
      <arm_group_label>Surveillance</arm_group_label>
      <description>20 AAA patients will undergo two MRI scans with a half year interval to assess a possible correlation between MRI derived biomarkers and the clinical standard to assess aneurysm progression (maximum AAA diameter).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EVAR planning</arm_group_label>
      <description>10 patients will undergo magnetic resonance angiography next the the standard of CT angiography (CTA). We want to find out whether we can plan an EVAR also based on MRA or that there would be great differences.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EVAR follow-up</arm_group_label>
      <description>30 AAA patients who underwent EVAR will be included in three groups: 10 patients with no complications ten year after EVAR or sac regression, 10 patients with endoleak type I and 10 patients with endoleak type II. We want to know if MRI can give extra information for the detection of endoleaks after EVAR.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Magnetic resonance imaging (with PROUD software)</intervention_name>
      <description>Philips Ingenia 3.0T MR system with in-house developed PROUD software</description>
      <arm_group_label>EVAR follow-up</arm_group_label>
      <arm_group_label>EVAR planning</arm_group_label>
      <arm_group_label>Surveillance</arm_group_label>
      <other_name>4D flow MRI</other_name>
      <other_name>DCE-MRI</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with an AAA from the Amsterdam UMC&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with AAA&#xD;
  &#xD;
            -  provision of written informed consent&#xD;
  &#xD;
          Inclusion Criteria for surveillance part:&#xD;
  &#xD;
            -  maximum AAA diameter between 3-5 cm&#xD;
  &#xD;
            -  not scheduled for aneurysm repair at the time of inclusion&#xD;
  &#xD;
          Inclusion Criteria for planning part:&#xD;
  &#xD;
            -  planned for elective EVAR&#xD;
  &#xD;
          Inclusion Criteria for follow-up part:&#xD;
  &#xD;
            -  ten complication free years after EVAR or sac regression after EVAR; or&#xD;
  &#xD;
            -  type I endoleak after EVAR; or&#xD;
  &#xD;
            -  type II endoleak after EVAR;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Supra- or pararenal AAA&#xD;
  &#xD;
            -  Inflammatory, infectious or mycotic AAA&#xD;
  &#xD;
            -  Vasculitis and connective tissue disease&#xD;
  &#xD;
            -  Patients that underwent open surgical repair for their AAA&#xD;
  &#xD;
            -  Patients with ruptured AAAs&#xD;
  &#xD;
            -  Patients that previously presented with allergic reactions to intravenous contrast&#xD;
               agents&#xD;
  &#xD;
          Exclusion Criteria for surveillance part:&#xD;
  &#xD;
            -  previous AAA repair&#xD;
  &#xD;
            -  severly reduced renal function&#xD;
  &#xD;
            -  previous allergic reactions to intravenous contrast agents&#xD;
  &#xD;
          Exclusion Criteria for planning part:&#xD;
  &#xD;
            -  previous AAA repair&#xD;
  &#xD;
          Exclusion Criteria for follow-up part:&#xD;
  &#xD;
            -  severly reduced renal function&#xD;
  &#xD;
            -  previous allergic reactions to intravenous contrast agents&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Amsterdam UMC</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1105 AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kak Khee Yeung, Phd</last_name>
        <phone>+31614278725</phone>
        <email>k.yeung@amsterdamumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Eva Aalbregt, Drs</last_name>
        <phone>+31652556974</phone>
        <email>e.aalbregt@amsterdamumc.nl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Associate Prof. Dr. Kak Khee Yeung</investigator_full_name>
      <investigator_title>Amsterdam UMC</investigator_title>
    </responsible_party>
    <keyword>Abdominal Aortic Aneurysm</keyword>
    <keyword>Magnetic Resonance Imaging</keyword>
    <keyword>4D flow MRI</keyword>
    <keyword>DCE MRI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm</mesh_term>
      <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
      <mesh_term>Rupture</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976711
  org study id: 2008987
  nct id: NCT05976711
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly
        which can rupture leading to bleeding within the belly. To prevent rupture elective surgery
        can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is
        inserted into the AAA to prevent it from further growth and rupture.
  
        Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to
        determine upon timing of elective repair but is unprecise in predicting the risk of rupture
        resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurence remain
        unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US)
        utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly
        exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the
        standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced
        MRI techniques are used to find out if standard imaging techniques could be replaced by MRI
        in three phases of the AAA management (surveillance, surgery planning and post-operative
        follow-up). The two most important MRI techniques that will be used are 4D flow MRI and
        dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow
        within the AAA and perfusion of the aortic wall.
  observational model: Cohort
  time perspective: Prospective
  measure: Surveillance: correlation between growth rate and MRI derived parameters
  time frame: 1 year
  description: The main study parameter for phase B1 (surveillance) is the correlation between growth rate of the AAA (determinant for the standard of care) and measured MRI parameters acquired with 4D flow MRI and DCE-MRI.
  measure: EVAR planning: correlation between morphological parameters measured based on MRA and CTA
  time frame: half year
  description: The main study parameter for phase B2 (EVAR planning) is the difference between anatomical measurements (lengths and diameters) based on both CTA and MRA. Several quantitative anatomical measurements will be utilised to assess the feasibility of MRA for planning of EVARs.
  measure: EVAR follow up: difference in MRI parameters between patients with endoleaks and without
  time frame: 1 year
  description: The main study parameter for phase B3 (EVAR follow-up) is the difference in MRI parameters measured post-operatively in patients with and without EVAR related complications.
  arm group label: Surveillance
  description: 20 AAA patients will undergo two MRI scans with a half year interval to assess a possible correlation between MRI derived biomarkers and the clinical standard to assess aneurysm progression (maximum AAA diameter).
  arm group label: EVAR planning
  description: 10 patients will undergo magnetic resonance angiography next the the standard of CT angiography (CTA). We want to find out whether we can plan an EVAR also based on MRA or that there would be great differences.
  arm group label: EVAR follow-up
  description: 30 AAA patients who underwent EVAR will be included in three groups: 10 patients with no complications ten year after EVAR or sac regression, 10 patients with endoleak type I and 10 patients with endoleak type II. We want to know if MRI can give extra information for the detection of endoleaks after EVAR.
  intervention type: Device
  intervention name: Magnetic resonance imaging (with PROUD software)
  description: Philips Ingenia 3.0T MR system with in-house developed PROUD software
  arm group label: EVAR follow-up
  arm group label: EVAR planning
  arm group label: Surveillance
  other name: 4D flow MRI
  other name: DCE-MRI
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Associate Prof. Dr. Kak Khee Yeung
  investigator title: Amsterdam UMC
  mesh term: Aneurysm
  mesh term: Aortic Aneurysm
  mesh term: Aortic Aneurysm, Abdominal
  mesh term: Rupture
  sharing ipd: No