Liver DiseasesNCT03279419
Thermal Imaging in Liver Disease.
An observational study of Liver Diseases, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Thermal imaging
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-70 with acute or chronic liver disease
Who may be able to join
- diagnosis of chronic liver disease (any stage)
- diagnosis of acute liver disease (any aetiology)
Who cannot join
- on drugs known to affect peripheral circulation
- conditions known to affect peripheral circulation e.g. Raynauds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Liver Diseases
- Being tested
- Thermal imaging
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imagingDiagnostic test
Use of thermal imaging camera to capture images of peripheral vasculature (hands).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Thermal imaging | |
| 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. Receives: Diagnostic Test: Thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral vasculature as assessed by thermal imaging
Measured: 2 years
Secondary outcomes (1)
Changes in peripheral vasculature in response to terlipressin therapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Sep 2019
- Primary completion1 Sep 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279419
- Sponsor's protocol ID
- IRAS ID 189169
- Status last verified
- Jun 2024
- First submitted
- 8 Sep 2017
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging of the Peripheral Vasculature in Liver Disease.
- ClinicalTrials.gov ID
- NCT03279419
- Acronym / sponsor ID
- IRAS ID 189169
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver disease | – | Diagnostic Test: Thermal imaging15 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. |
| Normal | – | Diagnostic Test: Thermal imaging15 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70 with acute or chronic liver disease
Key inclusion criteria (2 listed)
- diagnosis of chronic liver disease (any stage)
- diagnosis of acute liver disease (any aetiology)
Key exclusion criteria (2 listed)
- on drugs known to affect peripheral circulation
- conditions known to affect peripheral circulation e.g. Raynauds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal imagingUse of thermal imaging camera to capture images of peripheral vasculature (hands). | Diagnostic test | Liver disease, Normal |
Primary outcome
Changes in peripheral vasculature as assessed by thermal imaging
Time frame: 2 years
1 secondary outcome
Changes in peripheral vasculature in response to terlipressin therapy.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peripheral vasculature as assessed by thermal imaging (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.