Liver StiffnessFSNCT03947359
Effect of Thoracic Diameter and Food Intake on Fibroscan® Results
A study testing Fibroscan Touch 502 M probe and Fibroscan Touch 502 S probe in people with Liver Stiffness, run by Medical University of Graz at 1 site in Austria.
Trial summary
The study aims to deliver scientific data regarding the accuracy of the two different-sized Fibroscan® probes on patients with different thoracic diameter to gain more knowledge of the handling and measuring quality of the Fibroscan® as a diagnostic device and also to see if one probe is enough to measure a wider… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Stiffness
- What is being tested?
- Fibroscan Touch 502 M probe and Fibroscan Touch 502 S probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Interventional
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age > 18 for the adult Population
- Age 11-18 for the paediatric population
- Informed consent
- No history of liver disease
- Thoracic diameter >45 cm
Who cannot join
- Acute or chronic liver disease
- Any other disease or circumstance that may impact on the result of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Diameter and Food Intake on Fibroscan® Results: Comparison of the S - and M-probes
The study aims to deliver scientific data regarding the accuracy of the two different-sized Fibroscan® probes on patients with different thoracic diameter to gain more knowledge of the handling and measuring quality of the Fibroscan® as a diagnostic device and also to see if one probe is enough to measure a wider spectrum of patients leading to cost reduction for equipment such as additional probes.
Furthermore the study aims to analyze the effect of food intake on liver-stiffness measurements with the S-probe on children to shorten fasting periods. It is hypothesized that the fasting periods before a Fibroscan® measurement may be shortened, which is of special importance in smaller children.
Read the detailed description
The Fibroscan® (Echosens, France) is an ultrasound-based, non-invasive and non-painful diagnostic device which also has no complications and can be repeated easily to measure liver-stiffness by transient elastography. The company's device was first released and put on the market in 2003. The device can measure liver stiffness and liver fat content (controlled attenuation parameter CAP).
It is used for the identification and graduation of liver pathologies such as fibrosis and cirrhosis and it can be used on adults and children alike. Therefore patients with chronic liver diseases such as hepatitis C, hepatitis B, alcoholic liver disease as well as metabolic steatohepatitis and different biliary diseases can be examined with it.
Currently the standard procedure for grading fibrosis and cirrhosis still is the liver biopsy, however studies have compared the two procedures in context with different liver conditions like non-alcoholic fatty liver disease or hepatitis C and partially demonstrated that in terms of measuring liver-stiffness the Fibroscan® can rival the liver biopsy.
Usually the Fibroscan® measurements are performed using different probes that vary in frequency and penetration depth depending on the thoracic diameter of the patient. These probes are then applied in an intercostal space on the right side on the level of the liver.
The company Echosens that is producing the currently used model of the Fibroscan® alongside its different-sized probes claims that their S-sized probe is to be used for patients with a thoracic diameter below 75 cm and that their M-sized probe for patients above 75 cm diameter because otherwise the results would not be accurate. The company claims that using the M-sized probe on a patient with a thoracic diameter below 75 cm would cause wrong measurements. However, there is no data or studies that actually have compared the S- and the M- probe to each other and therefore the accuracy of the statement from Echosens is scientifically yet to be confirmed. So far only data on comparison of the M and XL-probe have been published.
Furthermore, food intake seems to impact on Fibroscan® -measurements. It has been already proven in past studies that food intake indeed has an effect on liver-stiffness and therefore influences the quality of Fibroscan® -measurements. All these studies revealed that it is the best to measure the patients while in a fasting condition for several hours. However, these studies all were performed on adults with different kinds of liver-diseases using the M-probe. So far, no data on the impact of food intake on measurements with the S-probe have been published.
Since it is to be expected that because of its attributes transient elastography will gain even more importance as a diagnostic device in the future, it is very significant to produce as much of valid data as possible.
- Conditions
- Liver Stiffness
- Being tested
- Fibroscan Touch 502 M probe, Fibroscan Touch 502 S probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan Touch 502 M probeDiagnostic test
Measurement of liver stiffness
Fibroscan Touch 502 S probeDiagnostic test
Measurement of liver stiffness
| Study group | Role | What they receive |
|---|---|---|
| Participants with a thoracic diameter < 75 cm | Other | Measurement of liver stiffness before and after a standardized meal with different probes Receives: Diagnostic Test: Fibroscan Touch 502 M probe; Diagnostic Test: Fibroscan Touch 502 S probe |
| Participants with a thoracic diameter >75 cm | Other | Measurement of liver stiffness before and after a standardized meal with different probes Receives: Diagnostic Test: Fibroscan Touch 502 M probe; Diagnostic Test: Fibroscan Touch 502 S probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver stiffness
Comparison of liver stiffness measurements at baseline with M- and S- probe
Measured: baseline
Secondary outcomes (4)
Liver stiffness
Measurement of liver stiffness measurements with M- probe after a standardized meal
Measured: 120 minutes
Liver stiffness
Measurement of liver stiffness measurements with S- probe after a standardized meal
Measured: 120 minutes
Liver fat content
Controlled attenuation parameter measured with M probe
Measured: baseline
Liver fat content
Controlled attenuation parameter measured with S probe
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Jun 2019
- Primary completion19 Oct 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver StiffnessStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy volunteers
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947359
- Sponsor's protocol ID
- Fibroscan_V1
- Acronym
- FS
- Status last verified
- Feb 2021
- First submitted
- 9 May 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Diameter and Food Intake on Fibroscan® Results: Comparison of the S - and M-probes
- ClinicalTrials.gov ID
- NCT03947359
- Acronym / sponsor ID
- FS / Fibroscan_V1
- Conditions
- Liver Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 19 Oct 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 May 2019 (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.
The study aims to deliver scientific data regarding the accuracy of the two different-sized Fibroscan® probes on patients with different thoracic diameter to gain more knowledge of the handling and measuring quality of the Fibroscan® as a diagnostic device and also to see if one probe is enough to measure a wider spectrum of patients leading to cost reduction for equipment such as additional probes.
Furthermore the study aims to analyze the effect of food intake on liver-stiffness measurements with the S-probe on children to shorten fasting periods. It is hypothesized that the fasting periods before a Fibroscan® measurement may be shortened, which is of special importance in smaller children.
Detailed description
The Fibroscan® (Echosens, France) is an ultrasound-based, non-invasive and non-painful diagnostic device which also has no complications and can be repeated easily to measure liver-stiffness by transient elastography. The company's device was first released and put on the market in 2003. The device can measure liver stiffness and liver fat content (controlled attenuation parameter CAP).
It is used for the identification and graduation of liver pathologies such as fibrosis and cirrhosis and it can be used on adults and children alike. Therefore patients with chronic liver diseases such as hepatitis C, hepatitis B, alcoholic liver disease as well as metabolic steatohepatitis and different biliary diseases can be examined with it.
Currently the standard procedure for grading fibrosis and cirrhosis still is the liver biopsy, however studies have compared the two procedures in context with different liver conditions like non-alcoholic fatty liver disease or hepatitis C and partially demonstrated that in terms of measuring liver-stiffness the Fibroscan® can rival the liver biopsy.
Usually the Fibroscan® measurements are performed using different probes that vary in frequency and penetration depth depending on the thoracic diameter of the patient. These probes are then applied in an intercostal space on the right side on the level of the liver.
The company Echosens that is producing the currently used model of the Fibroscan® alongside its different-sized probes claims that their S-sized probe is to be used for patients with a thoracic diameter below 75 cm and that their M-sized probe for patients above 75 cm diameter because otherwise the results would not be accurate. The company claims that using the M-sized probe on a patient with a thoracic diameter below 75 cm would cause wrong measurements. However, there is no data or studies that actually have compared the S- and the M- probe to each other and therefore the accuracy of the statement from Echosens is scientifically yet to be confirmed. So far only data on comparison of the M and XL-probe have been published.
Furthermore, food intake seems to impact on Fibroscan® -measurements. It has been already proven in past studies that food intake indeed has an effect on liver-stiffness and therefore influences the quality of Fibroscan® -measurements. All these studies revealed that it is the best to measure the patients while in a fasting condition for several hours. However, these studies all were performed on adults with different kinds of liver-diseases using the M-probe. So far, no data on the impact of food intake on measurements with the S-probe have been published.
Since it is to be expected that because of its attributes transient elastography will gain even more importance as a diagnostic device in the future, it is very significant to produce as much of valid data as possible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Participants with a thoracic diameter < 75 cm | Other | Diagnostic Test: Fibroscan Touch 502 M probe, Diagnostic Test: Fibroscan Touch 502 S probeMeasurement of liver stiffness before and after a standardized meal with different probes |
| Participants with a thoracic diameter >75 cm | Other | Diagnostic Test: Fibroscan Touch 502 M probe, Diagnostic Test: Fibroscan Touch 502 S probeMeasurement of liver stiffness before and after a standardized meal with different probes |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 for the adult Population
- Age 11-18 for the paediatric population
- Informed consent
- No history of liver disease
- Thoracic diameter >45 cm
Key exclusion criteria (2 listed)
- Acute or chronic liver disease
- Any other disease or circumstance that may impact on the result of the study
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 |
|---|---|---|
| Fibroscan Touch 502 M probeMeasurement of liver stiffness | Diagnostic test | Participants with a thoracic diameter < 75 cm, Participants with a thoracic diameter >75 cm |
| Fibroscan Touch 502 S probeMeasurement of liver stiffness | Diagnostic test | Participants with a thoracic diameter < 75 cm, Participants with a thoracic diameter >75 cm |
Primary outcome
Liver stiffness
Time frame: baseline
Comparison of liver stiffness measurements at baseline with M- and S- probe
4 secondary outcomes
Liver stiffness
Time frame: 120 minutes
Liver stiffness
Time frame: 120 minutes
Liver fat content
Time frame: baseline
Liver fat content
Time frame: 120 minutes
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 5 Feb 2021.
- 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?
A study testing Fibroscan Touch 502 M probe and Fibroscan Touch 502 S probe in people with Liver Stiffness, run by Medical University of Graz at 1 site in Austria.
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 5 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 5 Feb 2021. 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 Austria. 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?
Liver stiffness (time frame: baseline). 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 5 Feb 2021.