<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/NCT03289884</url>
  </required_header>
  <id_info>
    <org_study_id>16/0811</org_study_id>
    <nct_id>NCT03289884</nct_id>
  </id_info>
  <brief_title>MR Assessment of Hepatic Hydatid Disease</brief_title>
  <official_title>Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hydatid disease is a major healthcare problem worldwide caused by infection that commonly&#xD;
      affects the liver. Treatments for hydatid disease depend on how advanced the disease is and&#xD;
      if the infection is active or not. Currently, doctors decide what stage the disease is at by&#xD;
      looking at the appearance of liver on scans and by performing blood tests. It is however&#xD;
      still very difficult to be certain if a treatment is working and when is the right moment to&#xD;
      start and stop medication. Magnetic Resonance Imaging (MRI) scanning is a safe and&#xD;
      non-invasive way of imaging the liver that can provide detailed information not just about&#xD;
      what the liver looks like but also other information about the chemical composition of normal&#xD;
      and diseased liver tissue. MRI is already widely used in the NHS for many liver conditions&#xD;
      but it is unknown whether analysing the chemical composition will help decide on the stage&#xD;
      and activity of hydatid liver disease. This study will allow comparison between MRI&#xD;
      information about liver structure and composition with existing methods of assessing disease&#xD;
      stage. If fluid is later obtained from the liver as part of usual clinical care (either using&#xD;
      a needle with ultrasound or at the time of surgery), this study will also compare information&#xD;
      about the fluid composition obtained from MRI scanning, with the results obtained when&#xD;
      analysing the fluid in the lab. This will help to develop a more accurate way of&#xD;
      non-invasively assessing hydatid disease in the liver, in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cystic echincoccosis (CE), caused by infection with the dog tapeworm, is a major worldwide&#xD;
      healthcare problem with increasing prevalence in the developed world. Approximately 75% of CE&#xD;
      involves the liver, with treatments incurring significant cost and patient morbidity.&#xD;
&#xD;
      The key to CE treatment is correct identification of active infection but differentiation&#xD;
      from sterile disease is highly problematic. Current treatment guidelines base activity&#xD;
      assessment on morphological assessment with ultrasound (US), serology and light-microscopy of&#xD;
      samples obtained at aspiration/surgery when available. Serology however can take many years&#xD;
      to become negative even following successful treatment and US evaluation is subjective.&#xD;
      Assessment of disease 'activity' is therefore a major challenge, particularly once patients&#xD;
      are undergoing treatment. The lack of accurate tools to assess treatment response has&#xD;
      undermined the development of management guidelines, particularly concerning the optimum&#xD;
      length of chemotherapy treatment and indications for surgical/image-guided intervention.&#xD;
&#xD;
      Quantitative MR methods present a potential solution to this challenge. Magnetic Resonance&#xD;
      Spectroscopy (MRS) has shown promising ex vivo results in detecting the biochemical&#xD;
      &quot;signature&quot; of active infection in cyst fluid, but has yet to be applied clinically.&#xD;
      Alternative approaches including T1 mapping, susceptibility mapping and Diffusion Weighted&#xD;
      Imaging/Intra-voxel Incoherent Motion are also potentially useful, but have little supportive&#xD;
      data to date.&#xD;
&#xD;
      Non-invasive biomarkers of CE activity are therefore essential to defining specific treatment&#xD;
      endpoints, particularly in the context of chemotherapy. Multiple quantitative MR methods&#xD;
      could be used to develop composite biomarkers for disease activity. Identifying a new&#xD;
      quantitative radiological 'fingerprint' for each stage of the natural life-cycle of hepatic&#xD;
      CE will enable improved diagnosis and therapeutic triage.&#xD;
&#xD;
      To date, in vivo liver quantitative MRI has not yet been applied to this cohort of patients,&#xD;
      thus representing a novel application of this technology to address an important clinical&#xD;
      question.&#xD;
&#xD;
      With this pilot study, the investigators aim to demonstrate the potential of quantitative MRI&#xD;
      methods in the assessment of active/inactive hepatic CE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure is MR spectroscopy metabolite</measure>
    <time_frame>1 year</time_frame>
    <description>This will be assessed on water ratio</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Cystic Echincoccosis</condition>
  <condition>Hydatid Disease</condition>
  <arm_group>
    <arm_group_label>Control Group (CE1)</arm_group_label>
    <description>All patients must have cystic lesions which must exceed 30mm in diameter.&#xD;
All patients must be aged 16 or over and able to provide informed consent.&#xD;
Patients will have an MRI scan (not involving ionising radiation)&#xD;
Patients wil have an 'Ultrasound scan (not involving ionising radiation)'&#xD;
Exclusion criteria include pregnancy and any contraindication to MRI (pacemaker, metallic implants, claustrophobia) and inability to give consent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CE group (CE2-4)</arm_group_label>
    <description>All patients must have hepatic CE, as confirmed by positive blood tests, with lesions identified on the standard of care MRI/CT scan, one or more of which must exceed 20 mm in diameter.&#xD;
All patients must be aged 16 or over and able to provide informed consent.&#xD;
All patients will have an MRI scan (not involving ionising radiation)&#xD;
Patients wil have an 'Ultrasound scan (not involving ionising radiation)'&#xD;
Exclusion criteria include pregnancy and any contraindication to MRI (pacemaker, metallic implants, claustrophobia) and inability to give consent.&#xD;
Patients from the CE group undergoing surgery or aspiration will have fluid samples sent for analysis as part of standard clinical care. These cyst fluid samples will then be transported to the MRI scanner for Ex vivo scanning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI scan (not involving ionising radiation)</intervention_name>
    <description>The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher</description>
    <arm_group_label>CE group (CE2-4)</arm_group_label>
    <arm_group_label>Control Group (CE1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound scan (not involving ionising radiation)</intervention_name>
    <description>The US scan will be conducted by a nominated researcher</description>
    <arm_group_label>CE group (CE2-4)</arm_group_label>
    <arm_group_label>Control Group (CE1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ex vivo MRI scan of cyst fluid sample</intervention_name>
    <description>The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher</description>
    <arm_group_label>CE group (CE2-4)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aspiration of cyst fluid</intervention_name>
    <description>For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist</description>
    <arm_group_label>CE group (CE2-4)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood test for confirmation of serum IgG levels consistent with hydatid infection</intervention_name>
    <description>The blood sample will be drawn by a member of the clinical team</description>
    <arm_group_label>CE group (CE2-4)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment will take place at the hydatid liver disease multidisciplinary team meetings&#xD;
        where patients are discussed and considered for inclusion. These patients can be recruited&#xD;
        via outpatient consultation clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Control group:&#xD;
&#xD;
          -  All patients must have cystic lesions which must exceed 30 mm in diameter.&#xD;
&#xD;
          -  All patients must be fasted and avoid caffeinated fluids for at least 4 hours prior to&#xD;
             the scan.&#xD;
&#xD;
          -  All patients must be aged 16 or over and able to provide informed consent.&#xD;
&#xD;
        Inclusion Criteria for the CE group:&#xD;
&#xD;
          -  All patients must have hepatic CE, as confirmed by positive serology, with lesions&#xD;
             identified on teh standard of care MRI/CT scan, one or more of which must exceed 20 mm&#xD;
             in diameter.&#xD;
&#xD;
          -  All patients must be fasted and avoid caffeinated fluids for at least 4 hours prior to&#xD;
             the scan.&#xD;
&#xD;
          -  All patients must be aged 16 or over and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any contraindication to MRI (pacemakers, metallic implants, claustrophobia ect.)&#xD;
&#xD;
          -  Inability to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manil Chouhan, MBBS BSc</last_name>
    <phone>07779783511</phone>
    <email>m.chouhan@ucl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katerina Soteriou, BSc</last_name>
    <email>katerina.soteriou@uclh.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University College London Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manil Chouhan, MBBS BSc</last_name>
      <phone>07779783511</phone>
      <email>m.chouhan@ucl.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Katerina Soteriou, BSc</last_name>
      <email>katerina.soteriou@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Brunetti E, Garcia HH, Junghanss T; International CE Workshop in Lima, Peru, 2009. Cystic echinococcosis: chronic, complex, and still neglected. PLoS Negl Trop Dis. 2011 Jul;5(7):e1146. doi: 10.1371/journal.pntd.0001146. Epub 2011 Jul 26. No abstract available.</citation>
    <PMID>21814584</PMID>
  </reference>
  <reference>
    <citation>Budke CM, Deplazes P, Torgerson PR. Global socioeconomic impact of cystic echinococcosis. Emerg Infect Dis. 2006 Feb;12(2):296-303. doi: 10.3201/eid1202.050499.</citation>
    <PMID>16494758</PMID>
  </reference>
  <reference>
    <citation>Anand S, Rajagopalan S, Mohan R. Management of liver hydatid cysts - Current perspectives. Med J Armed Forces India. 2012 Jul;68(3):304-9. doi: 10.1016/j.mjafi.2012.04.010.</citation>
    <PMID>24532894</PMID>
  </reference>
  <reference>
    <citation>Benner C, Carabin H, Sanchez-Serrano LP, Budke CM, Carmena D. Analysis of the economic impact of cystic echinococcosis in Spain. Bull World Health Organ. 2010 Jan;88(1):49-57. doi: 10.2471/BLT.09.066795. Erratum In: Bull World Health Organ. 2010 Mar;88(3):236.</citation>
    <PMID>20428353</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</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>Echinococcosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03289884
org study id: 16/0811
nct id: NCT03289884
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hydatid disease is a major healthcare problem worldwide caused by infection that commonly
      affects the liver. Treatments for hydatid disease depend on how advanced the disease is and
      if the infection is active or not. Currently, doctors decide what stage the disease is at by
      looking at the appearance of liver on scans and by performing blood tests. It is however
      still very difficult to be certain if a treatment is working and when is the right moment to
      start and stop medication. Magnetic Resonance Imaging (MRI) scanning is a safe and
      non-invasive way of imaging the liver that can provide detailed information not just about
      what the liver looks like but also other information about the chemical composition of normal
      and diseased liver tissue. MRI is already widely used in the NHS for many liver conditions
      but it is unknown whether analysing the chemical composition will help decide on the stage
      and activity of hydatid liver disease. This study will allow comparison between MRI
      information about liver structure and composition with existing methods of assessing disease
      stage. If fluid is later obtained from the liver as part of usual clinical care (either using
      a needle with ultrasound or at the time of surgery), this study will also compare information
      about the fluid composition obtained from MRI scanning, with the results obtained when
      analysing the fluid in the lab. This will help to develop a more accurate way of
      non-invasively assessing hydatid disease in the liver, in the future.
Cystic echincoccosis (CE), caused by infection with the dog tapeworm, is a major worldwide
      healthcare problem with increasing prevalence in the developed world. Approximately 75% of CE
      involves the liver, with treatments incurring significant cost and patient morbidity.

      The key to CE treatment is correct identification of active infection but differentiation
      from sterile disease is highly problematic. Current treatment guidelines base activity
      assessment on morphological assessment with ultrasound (US), serology and light-microscopy of
      samples obtained at aspiration/surgery when available. Serology however can take many years
      to become negative even following successful treatment and US evaluation is subjective.
      Assessment of disease 'activity' is therefore a major challenge, particularly once patients
      are undergoing treatment. The lack of accurate tools to assess treatment response has
      undermined the development of management guidelines, particularly concerning the optimum
      length of chemotherapy treatment and indications for surgical/image-guided intervention.

      Quantitative MR methods present a potential solution to this challenge. Magnetic Resonance
      Spectroscopy (MRS) has shown promising ex vivo results in detecting the biochemical
      "signature" of active infection in cyst fluid, but has yet to be applied clinically.
      Alternative approaches including T1 mapping, susceptibility mapping and Diffusion Weighted
      Imaging/Intra-voxel Incoherent Motion are also potentially useful, but have little supportive
      data to date.

      Non-invasive biomarkers of CE activity are therefore essential to defining specific treatment
      endpoints, particularly in the context of chemotherapy. Multiple quantitative MR methods
      could be used to develop composite biomarkers for disease activity. Identifying a new
      quantitative radiological 'fingerprint' for each stage of the natural life-cycle of hepatic
      CE will enable improved diagnosis and therapeutic triage.

      To date, in vivo liver quantitative MRI has not yet been applied to this cohort of patients,
      thus representing a novel application of this technology to address an important clinical
      question.

      With this pilot study, the investigators aim to demonstrate the potential of quantitative MRI
      methods in the assessment of active/inactive hepatic CE.
observational model: Other
time perspective: Cross-Sectional
measure: The primary outcome measure is MR spectroscopy metabolite
time frame: 1 year
description: This will be assessed on water ratio
arm group label: Control Group (CE1)
description: All patients must have cystic lesions which must exceed 30mm in diameter.
All patients must be aged 16 or over and able to provide informed consent.
Patients will have an MRI scan (not involving ionising radiation)
Patients wil have an 'Ultrasound scan (not involving ionising radiation)'
Exclusion criteria include pregnancy and any contraindication to MRI (pacemaker, metallic implants, claustrophobia) and inability to give consent.
arm group label: CE group (CE2-4)
description: All patients must have hepatic CE, as confirmed by positive blood tests, with lesions identified on the standard of care MRI/CT scan, one or more of which must exceed 20 mm in diameter.
All patients must be aged 16 or over and able to provide informed consent.
All patients will have an MRI scan (not involving ionising radiation)
Patients wil have an 'Ultrasound scan (not involving ionising radiation)'
Exclusion criteria include pregnancy and any contraindication to MRI (pacemaker, metallic implants, claustrophobia) and inability to give consent.
Patients from the CE group undergoing surgery or aspiration will have fluid samples sent for analysis as part of standard clinical care. These cyst fluid samples will then be transported to the MRI scanner for Ex vivo scanning.
intervention type: Other
intervention name: MRI scan (not involving ionising radiation)
description: The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
arm group label: CE group (CE2-4)
arm group label: Control Group (CE1)
intervention type: Other
intervention name: Ultrasound scan (not involving ionising radiation)
description: The US scan will be conducted by a nominated researcher
arm group label: CE group (CE2-4)
arm group label: Control Group (CE1)
intervention type: Other
intervention name: Ex vivo MRI scan of cyst fluid sample
description: The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
arm group label: CE group (CE2-4)
intervention type: Other
intervention name: Aspiration of cyst fluid
description: For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist
arm group label: CE group (CE2-4)
intervention type: Other
intervention name: Blood test for confirmation of serum IgG levels consistent with hydatid infection
description: The blood sample will be drawn by a member of the clinical team
arm group label: CE group (CE2-4)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Manil Chouhan, MBBS BSc
phone: 07779783511
email: m.chouhan@ucl.ac.uk
last name: Katerina Soteriou, BSc
email: katerina.soteriou@uclh.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
citation: Brunetti E, Garcia HH, Junghanss T; International CE Workshop in Lima, Peru, 2009. Cystic echinococcosis: chronic, complex, and still neglected. PLoS Negl Trop Dis. 2011 Jul;5(7):e1146. doi: 10.1371/journal.pntd.0001146. Epub 2011 Jul 26. No abstract available.
PMID: 21814584
citation: Budke CM, Deplazes P, Torgerson PR. Global socioeconomic impact of cystic echinococcosis. Emerg Infect Dis. 2006 Feb;12(2):296-303. doi: 10.3201/eid1202.050499.
PMID: 16494758
citation: Anand S, Rajagopalan S, Mohan R. Management of liver hydatid cysts - Current perspectives. Med J Armed Forces India. 2012 Jul;68(3):304-9. doi: 10.1016/j.mjafi.2012.04.010.
PMID: 24532894
citation: Benner C, Carabin H, Sanchez-Serrano LP, Budke CM, Carmena D. Analysis of the economic impact of cystic echinococcosis in Spain. Bull World Health Organ. 2010 Jan;88(1):49-57. doi: 10.2471/BLT.09.066795. Erratum In: Bull World Health Organ. 2010 Mar;88(3):236.
PMID: 20428353
responsible party type: Sponsor
mesh term: Echinococcosis