Liver FibrosisNCT03637959
Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
A study testing Mechanical Vibrations with Ultrasound Shear Wave Imaging in people with Liver Fibrosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Mechanical Vibrations with Ultrasound Shear Wave Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 4 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
- Age 18 to 80.
Who cannot join
- Subjects lacking capacity to consent
- Subjects with unreliable ultrasound or MRE measurements.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.
Read the detailed description
Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.
- Conditions
- Liver Fibrosis
- Being tested
- Mechanical Vibrations with Ultrasound Shear Wave Imaging
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Vibrations with Ultrasound Shear Wave ImagingDevice
Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Vibrations with Ultrasound Shear Wave Imaging | Experimental | Subjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness Receives: Device: Mechanical Vibrations with Ultrasound Shear Wave Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness Measured by MRE
Liver stiffness measured by standard of care Magnetic Resonance Elastography reported in Kilopascals (kPa) (used as a benchmark reference in this study).
Measured: Baseline, approximately 1 day
Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging
Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).
Measured: Baseline, approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start26 Jan 2017
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiago Chen, Mayo Clinic
- Investigators
- Shigao Chen, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637959
- Sponsor's protocol ID
- 13-002289
- Other IDs
- R01DK106957
- Status last verified
- Dec 2021
- First submitted
- 14 Aug 2018
- Last updated
- 13 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
- ClinicalTrials.gov ID
- NCT03637959
- Acronym / sponsor ID
- 13-002289
- Conditions
- Liver Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 13 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.
Detailed description
Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Vibrations with Ultrasound Shear Wave Imaging | Experimental | Device: Mechanical Vibrations with Ultrasound Shear Wave ImagingSubjects that are scheduled to undergo a clinical indicated Magnetic Resonance Elastography (MRE) will also have mechanical vibrations ultrasound shear wave imaging to measure liver stiffness |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
- Age 18 to 80.
Key exclusion criteria (3 listed)
- Subjects lacking capacity to consent
- Subjects with unreliable ultrasound or MRE measurements.
- Pregnant women.
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 |
|---|---|---|
| Mechanical Vibrations with Ultrasound Shear Wave ImagingMultiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination. | Device | Mechanical Vibrations with Ultrasound Shear Wave Imaging |
Primary outcome
Liver Stiffness Measured by MRE
Time frame: Baseline, approximately 1 day
Liver stiffness measured by standard of care Magnetic Resonance Elastography reported in Kilopascals (kPa) (used as a benchmark reference in this study).
Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging
Time frame: Baseline, approximately 1 day
Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Shigao Chen, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Vibrations with Ultrasound Shear Wave Imaging in people with Liver Fibrosis, run by Mayo Clinic at 1 site in United States.
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 3 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 13 Dec 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Measured by MRE (time frame: Baseline, approximately 1 day). The study lists 2 primary outcomes in all. 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 13 Dec 2021.