Thermal Imaging in Liver Disease.

June 17, 2024 updated by: University of Edinburgh

Thermal Imaging of the Peripheral Vasculature in Liver Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • Univerity of Edinburgh and NHS Lothian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18-70 with acute or chronic liver disease

Description

Inclusion Criteria:

  • diagnosis of chronic liver disease (any stage)
  • diagnosis of acute liver disease (any aetiology)

Exclusion Criteria:

  • on drugs known to affect peripheral circulation
  • conditions known to affect peripheral circulation e.g. Raynauds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver disease

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.
Diagnostic test: Thermal imaging
Use of thermal imaging camera to capture images of peripheral vasculature (hands).
Normal

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.
Diagnostic test: Thermal imaging
Use of thermal imaging camera to capture images of peripheral vasculature (hands).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in peripheral vasculature as assessed by thermal imaging
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in peripheral vasculature in response to terlipressin therapy.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS ID 189169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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