<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/NCT03809559</url>
  </required_header>
  <id_info>
    <org_study_id>MRCP_RR</org_study_id>
    <nct_id>NCT03809559</nct_id>
  </id_info>
  <brief_title>Repeatability and Reproducibility of Quantitative MRCP</brief_title>
  <official_title>Repeatability and Reproducibility of Quantitative MRCP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Perspectum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Perspectum</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>
      This study aims to determine the repeatability and reproducibility of Quantitative Magnetic&#xD;
      Resonance Cholangiopancreatography (MRCP).&#xD;
&#xD;
      Imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical&#xD;
      model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative&#xD;
      MRCP'. This enables advanced quantitative measurement of bile duct width, orientation,&#xD;
      branching point and curvative metrics.&#xD;
&#xD;
      The technology has been validated against 3D printed phantoms for accuracy, and early&#xD;
      clinical research has demonstrated the technology has potential for clinical impact, with&#xD;
      improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal&#xD;
      et al 2017).&#xD;
&#xD;
      Quantitative MRCP aims to act as a tool to not only improve assessment of the current status&#xD;
      of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it&#xD;
      must be established that any change between scans is due to change in the physiology of the&#xD;
      individual and not due to a quirk or fault of the technology.&#xD;
&#xD;
      In order to achieve this a series of scans will be performed on an individual over a short&#xD;
      period of time, for which the condition of the biliary tree within that individual can be&#xD;
      assumed to be constant. Between each scan, subject and coil repositioning will occur.&#xD;
&#xD;
      The study will recruit a group of adult volunteers, from both diseased groups and healthy&#xD;
      groups in order to achieve a range of physiological biliary metrics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biliary-related conditions, such as autoimmune conditions Primary Biliary Cholangitis (PBC),&#xD;
      and Primary Sclerosing Cholangitis (PSC), and also cancers such as cholangiocarcinoma, affect&#xD;
      tens of thousands of individuals in the UK each year. All biliary conditions require careful&#xD;
      tracking of the structure and integrity of the biliary tree so that intervention can be&#xD;
      carefully planned and with that, outcomes improved.&#xD;
&#xD;
      The current non-invasive gold-standard for assessment of the biliary tree is MRI-based&#xD;
      Magnetic Resonance Cholangiopancreatography (MRCP). This method uses no contrast and takes up&#xD;
      to 10 minutes to obtain within a normal scan event. However, there are several limitations to&#xD;
      its use which include, images having great variability in quality and are used mainly for&#xD;
      qualitative analysis. Using conventional MRCP a consultant can, depending on image quality;&#xD;
      identify key structures, inform diagnosis, and give a general assessment on the health of the&#xD;
      biliary tree structure. However, current MRCP imaging only allows limited quantitative&#xD;
      assessment of the ducts. More extensive, objective quantification has the potential to&#xD;
      dramatically improve the usability of MRCP imaging.With this in mind, imaging scientists at&#xD;
      Perspectum Diagnostics have developed a hessian-based mathematical model to enhance&#xD;
      conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This&#xD;
      enables quantitative measurement of bile duct width, orientation, branching point and&#xD;
      curvative metrics.&#xD;
&#xD;
      The technology has been validated against 3D printed phantoms for accuracy, and early&#xD;
      clinical research has demonstrated the technology has potential for clinical impact, with&#xD;
      improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal&#xD;
      et al 2017). Thus, further research into the technology and its viability as an enhancement&#xD;
      to current procedure is necessary if it is to replace conventional MRCP as the primary method&#xD;
      of non-invasive biliary assessment.&#xD;
&#xD;
      Integral to the development of any new technology, is demonstration of the repeatability and&#xD;
      reproducibility of the method. This is the inter-examination variability in results.&#xD;
      Quantitative MRCP aims to act as a tool to not only improve assessment of the current status&#xD;
      of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it&#xD;
      must be established that any change between scans is due to change in the physiology of the&#xD;
      individual and not due to a quirk or fault of the technology.&#xD;
&#xD;
      The above will be tested by a series of scans performed on an individual over a short period&#xD;
      of time, for which the condition of the biliary tree within that individual can be assumed to&#xD;
      be constant. Between each scan, subject and coil repositioning will occur. The study will&#xD;
      recruit a group of adult volunteers, from both diseased groups and healthy groups in order to&#xD;
      achieve a range of physiological biliary metrics.&#xD;
&#xD;
      Quantitative MRCP is an MRI based method, requiring no contrast, however consuming a drink&#xD;
      containing manganese improves the quality of MRCP images significantly (Frisch et al., 2017),&#xD;
      and therefore patients are routinely asked to drink pineapple juice (naturally high in&#xD;
      manganese) before having a clinical MRCP scan. At present, multiparametric MRI to assess the&#xD;
      health of liver tissue is performed in a fasted state (Banerjee et al., 2014), however, in&#xD;
      order to offer a comprehensive liver scan including both MRCP and multiparametric MRI in the&#xD;
      same scan, it is important to understand whether consuming pineapple juice will affect the&#xD;
      multiparametric MRI measurements of cT1, PDFF and T2*.&#xD;
&#xD;
      MRI is safe and non-invasive, with no known risks to patients as long as they are&#xD;
      appropriately screened to ensure they have no contraindications to MRI (e.g.pacemaker, metal&#xD;
      implant that is not certified as MR-safe).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2018</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">September 8, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Repeatability and Reproducibility of Quantitative MRCP</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the variability of bile duct volume, bile duct diameter, branching points and locations of regions of variation in bile duct widths and percentages, as measured by quantitative MRCP between:&#xD;
A. Repeated scans of the same participant acquired under the same conditions&#xD;
B. Repeated scans of the same participant acquired on scanners which differ by field strength and/or manufacturer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra and Inter-operator reproducibility</measure>
    <time_frame>6 months</time_frame>
    <description>Statistical assessment of the agreement among quantitative MRCP analyses performed by both trained operators and expert radiologists.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of conventional MRCP and quantitative MRCP</measure>
    <time_frame>6 months</time_frame>
    <description>Statistical assessment of the agreement between quantitative MRCP analyses (performed by both trained operators and expert radiologists) and clinician ground truth (biliary tree assessment obtained by expert radiologists using conventional MRCP)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of the impact of pineapple juice consumption upon LiverMultiScan performance</measure>
    <time_frame>6 months</time_frame>
    <description>Statistical assessment of the agreement among cT1, PDFF and T2* measurements before and after consuming pineapple juice.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Primary Sclerosing Cholangitis</condition>
  <condition>Primary Biliary Cirrhosis</condition>
  <condition>Gallstones</condition>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Biliary Conditions</arm_group_label>
    <description>Participants who have a history of a biliary tree related condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver conditions</arm_group_label>
    <description>Participants who have a history of a non-biliary tree related liver condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Participants who have do not have a diagnosed liver condition and are in general good health</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRCP+</intervention_name>
    <description>Participants will undergo an initial abdominal MRI scan in a fasted state. They will then be asked to drink 400ml pineapple juice before undergoing four further abdominal MRI scans with short breaks in between each scan.</description>
    <arm_group_label>Biliary Conditions</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Liver conditions</arm_group_label>
    <other_name>Quantitative Magnetic Resonance Cholangiopancreatography</other_name>
    <other_name>LiverMultiScan</other_name>
    <other_name>Multiparametric MRI</other_name>
    <other_name>MRI-PDFF</other_name>
    <other_name>MRCP</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be identified in one of two ways.&#xD;
&#xD;
          -  Participants who have previously taken part in one of Perspectum's ethically approved&#xD;
             studies and consented during that study to be contacted again in the event of any&#xD;
             future study.&#xD;
&#xD;
          -  Participants who self-identify via advertisement on Perspectum's online and social&#xD;
             media channels, or through collaboration with the investigator's charity partners.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons over the age of 18 years&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  EITHER: Participant has a medical history of a liver or biliary tree related condition&#xD;
             OR: Person is a healthy volunteer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant may not enter the study if they have any contraindication to magnetic&#xD;
             resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury,&#xD;
             severe claustrophobia).&#xD;
&#xD;
          -  The participant may not enter the study if they have an allergy to pineapple juice.&#xD;
&#xD;
          -  Any other cause, including a significant disease or disorder which, in the opinion of&#xD;
             the investigator, may either put the participant at risk because of participation in&#xD;
             the study, or may influence the participant's ability to participate in the study&#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>Rajarshi Banerjee, BM BCh MSc DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Perspectum Diagnostics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford Centre for Clinical Magnetic Resonance Research</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetic Resonance Cholangiopancreatography (MRCP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</mesh_term>
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Liver Cirrhosis, Biliary</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/NCT03809559
org study id: MRCP_RR
nct id: NCT03809559
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the repeatability and reproducibility of Quantitative Magnetic
      Resonance Cholangiopancreatography (MRCP).

      Imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical
      model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative
      MRCP'. This enables advanced quantitative measurement of bile duct width, orientation,
      branching point and curvative metrics.

      The technology has been validated against 3D printed phantoms for accuracy, and early
      clinical research has demonstrated the technology has potential for clinical impact, with
      improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal
      et al 2017).

      Quantitative MRCP aims to act as a tool to not only improve assessment of the current status
      of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it
      must be established that any change between scans is due to change in the physiology of the
      individual and not due to a quirk or fault of the technology.

      In order to achieve this a series of scans will be performed on an individual over a short
      period of time, for which the condition of the biliary tree within that individual can be
      assumed to be constant. Between each scan, subject and coil repositioning will occur.

      The study will recruit a group of adult volunteers, from both diseased groups and healthy
      groups in order to achieve a range of physiological biliary metrics.
Biliary-related conditions, such as autoimmune conditions Primary Biliary Cholangitis (PBC),
      and Primary Sclerosing Cholangitis (PSC), and also cancers such as cholangiocarcinoma, affect
      tens of thousands of individuals in the UK each year. All biliary conditions require careful
      tracking of the structure and integrity of the biliary tree so that intervention can be
      carefully planned and with that, outcomes improved.

      The current non-invasive gold-standard for assessment of the biliary tree is MRI-based
      Magnetic Resonance Cholangiopancreatography (MRCP). This method uses no contrast and takes up
      to 10 minutes to obtain within a normal scan event. However, there are several limitations to
      its use which include, images having great variability in quality and are used mainly for
      qualitative analysis. Using conventional MRCP a consultant can, depending on image quality;
      identify key structures, inform diagnosis, and give a general assessment on the health of the
      biliary tree structure. However, current MRCP imaging only allows limited quantitative
      assessment of the ducts. More extensive, objective quantification has the potential to
      dramatically improve the usability of MRCP imaging.With this in mind, imaging scientists at
      Perspectum Diagnostics have developed a hessian-based mathematical model to enhance
      conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This
      enables quantitative measurement of bile duct width, orientation, branching point and
      curvative metrics.

      The technology has been validated against 3D printed phantoms for accuracy, and early
      clinical research has demonstrated the technology has potential for clinical impact, with
      improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal
      et al 2017). Thus, further research into the technology and its viability as an enhancement
      to current procedure is necessary if it is to replace conventional MRCP as the primary method
      of non-invasive biliary assessment.

      Integral to the development of any new technology, is demonstration of the repeatability and
      reproducibility of the method. This is the inter-examination variability in results.
      Quantitative MRCP aims to act as a tool to not only improve assessment of the current status
      of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it
      must be established that any change between scans is due to change in the physiology of the
      individual and not due to a quirk or fault of the technology.

      The above will be tested by a series of scans performed on an individual over a short period
      of time, for which the condition of the biliary tree within that individual can be assumed to
      be constant. Between each scan, subject and coil repositioning will occur. The study will
      recruit a group of adult volunteers, from both diseased groups and healthy groups in order to
      achieve a range of physiological biliary metrics.

      Quantitative MRCP is an MRI based method, requiring no contrast, however consuming a drink
      containing manganese improves the quality of MRCP images significantly (Frisch et al., 2017),
      and therefore patients are routinely asked to drink pineapple juice (naturally high in
      manganese) before having a clinical MRCP scan. At present, multiparametric MRI to assess the
      health of liver tissue is performed in a fasted state (Banerjee et al., 2014), however, in
      order to offer a comprehensive liver scan including both MRCP and multiparametric MRI in the
      same scan, it is important to understand whether consuming pineapple juice will affect the
      multiparametric MRI measurements of cT1, PDFF and T2*.

      MRI is safe and non-invasive, with no known risks to patients as long as they are
      appropriately screened to ensure they have no contraindications to MRI (e.g.pacemaker, metal
      implant that is not certified as MR-safe).
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of Repeatability and Reproducibility of Quantitative MRCP
time frame: 6 months
description: Assessment of the variability of bile duct volume, bile duct diameter, branching points and locations of regions of variation in bile duct widths and percentages, as measured by quantitative MRCP between:
A. Repeated scans of the same participant acquired under the same conditions
B. Repeated scans of the same participant acquired on scanners which differ by field strength and/or manufacturer
measure: Intra and Inter-operator reproducibility
time frame: 6 months
description: Statistical assessment of the agreement among quantitative MRCP analyses performed by both trained operators and expert radiologists.
measure: Comparison of conventional MRCP and quantitative MRCP
time frame: 6 months
description: Statistical assessment of the agreement between quantitative MRCP analyses (performed by both trained operators and expert radiologists) and clinician ground truth (biliary tree assessment obtained by expert radiologists using conventional MRCP)
measure: Assessment of the impact of pineapple juice consumption upon LiverMultiScan performance
time frame: 6 months
description: Statistical assessment of the agreement among cT1, PDFF and T2* measurements before and after consuming pineapple juice.
arm group label: Biliary Conditions
description: Participants who have a history of a biliary tree related condition
arm group label: Liver conditions
description: Participants who have a history of a non-biliary tree related liver condition
arm group label: Healthy Volunteers
description: Participants who have do not have a diagnosed liver condition and are in general good health
intervention type: Device
intervention name: MRCP+
description: Participants will undergo an initial abdominal MRI scan in a fasted state. They will then be asked to drink 400ml pineapple juice before undergoing four further abdominal MRI scans with short breaks in between each scan.
arm group label: Biliary Conditions
arm group label: Healthy Volunteers
arm group label: Liver conditions
other name: Quantitative Magnetic Resonance Cholangiopancreatography
other name: LiverMultiScan
other name: Multiparametric MRI
other name: MRI-PDFF
other name: MRCP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rajarshi Banerjee, BM BCh MSc DPhil
role: Principal Investigator
affiliation: Perspectum Diagnostics
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing
mesh term: Gallstones
mesh term: Liver Cirrhosis, Biliary
sharing ipd: No