<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/NCT03279419</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS ID 189169</org_study_id>
    <nct_id>NCT03279419</nct_id>
  </id_info>
  <brief_title>Thermal Imaging in Liver Disease.</brief_title>
  <official_title>Thermal Imaging of the Peripheral Vasculature in Liver Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Edinburgh</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>
      This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will&#xD;
      be useful in identifying changes in the peripheral circulation in patients with different&#xD;
      stages of liver disease.&#xD;
&#xD;
      The aim of this study is to use new and advanced thermal imaging techniques to identify&#xD;
      changes in the peripheral circulation and hand temperature in patients with liver disease.&#xD;
      These changes could be used as a non-invasive marker of the severity and progression of liver&#xD;
      disease. Thermal imaging will also be used to assess the changes in the peripheral&#xD;
      vasculature with the use of terlipressin, a drug used as treatment for specific complications&#xD;
      of liver disease.&#xD;
&#xD;
      Patients with acute or chronic liver disease from any aetiology will be recruited, along with&#xD;
      patients without liver disease as healthy controls. Patients with disease or on drugs known&#xD;
      to affect the peripheral vasculature will be excluded.&#xD;
&#xD;
      All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The&#xD;
      subjects will be required for up to three sessions, each lasting 30 minutes. The session will&#xD;
      involve static thermal images being taken, and video images of the hands warming up after&#xD;
      being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is&#xD;
      receiving terlipressin therapy, static images will be taken before, during and after&#xD;
      terlipressin therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in peripheral vasculature as assessed by thermal imaging</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in peripheral vasculature in response to terlipressin therapy.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Liver disease</arm_group_label>
    <description>15 patients with acute or chronic liver disease of any aetiology. Serial static images to be taken at up to 3 time points using thermal imaging camera. Video images using thermal camera will be used to capture warming of one hand after cooling.&#xD;
Patient may or may not be receiving terlipressin therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>15 patients without liver disease, and without any other disease or drug known to affect the peripheral circulation.&#xD;
Serial static images to be taken at up to 3 time points using thermal imaging camera. Video images using thermal camera will be used to capture warming of one hand after cooling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thermal imaging</intervention_name>
    <description>Use of thermal imaging camera to capture images of peripheral vasculature (hands).</description>
    <arm_group_label>Liver disease</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 18-70 with acute or chronic liver disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of chronic liver disease (any stage)&#xD;
&#xD;
          -  diagnosis of acute liver disease (any aetiology)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  on drugs known to affect peripheral circulation&#xD;
&#xD;
          -  conditions known to affect peripheral circulation e.g. Raynauds&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mhairi Donnelly, MBChB</last_name>
    <phone>00447969824902</phone>
    <email>mhairi.donnelly@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Univerity of Edinburgh and NHS Lothian</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chric Coner</last_name>
      <email>chris.coner@ed.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</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>Liver Diseases</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/NCT03279419
org study id: IRAS ID 189169
nct id: NCT03279419
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will
      be useful in identifying changes in the peripheral circulation in patients with different
      stages of liver disease.

      The aim of this study is to use new and advanced thermal imaging techniques to identify
      changes in the peripheral circulation and hand temperature in patients with liver disease.
      These changes could be used as a non-invasive marker of the severity and progression of liver
      disease. Thermal imaging will also be used to assess the changes in the peripheral
      vasculature with the use of terlipressin, a drug used as treatment for specific complications
      of liver disease.

      Patients with acute or chronic liver disease from any aetiology will be recruited, along with
      patients without liver disease as healthy controls. Patients with disease or on drugs known
      to affect the peripheral vasculature will be excluded.

      All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The
      subjects will be required for up to three sessions, each lasting 30 minutes. The session will
      involve static thermal images being taken, and video images of the hands warming up after
      being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is
      receiving terlipressin therapy, static images will be taken before, during and after
      terlipressin therapy.
observational model: Case-Control
time perspective: Prospective
measure: Changes in peripheral vasculature as assessed by thermal imaging
time frame: 2 years
measure: Changes in peripheral vasculature in response to terlipressin therapy.
time frame: 2 years
arm group label: Liver disease
description: 15 patients with acute or chronic liver disease of any aetiology. Serial static images to be taken at up to 3 time points using thermal imaging camera. Video images using thermal camera will be used to capture warming of one hand after cooling.
Patient may or may not be receiving terlipressin therapy.
arm group label: Normal
description: 15 patients without liver disease, and without any other disease or drug known to affect the peripheral circulation.
Serial static images to be taken at up to 3 time points using thermal imaging camera. Video images using thermal camera will be used to capture warming of one hand after cooling.
intervention type: Diagnostic Test
intervention name: Thermal imaging
description: Use of thermal imaging camera to capture images of peripheral vasculature (hands).
arm group label: Liver disease
arm group label: Normal
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mhairi Donnelly, MBChB
phone: 00447969824902
email: mhairi.donnelly@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: No