Liver FibrosisNCT05154656
Three-Dimensional T1rho Using Spiral Fast Spin Echo
An observational study of Liver Fibrosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Liver fibrosis is the main feature in early chronic liver diseases. If identified early, liver fibrosis is reversible. The current gold standard for diagnosing liver fibrosis is invasive liver biopsy. Existing non-invasive methods still have significant limitations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to 30 Jun 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 60 patients with early stage of liver fibrosis and 60 subjects with no liver fibrosis
Who may be able to join
- Between age 18 and age 55
- patients with early liver fibrosis
- Informed written consent obtained
Who cannot join
- Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong, Prince of Wale Hospital
Hong Kong, Shatin
About this study
Official title: Fast Three-Dimensional Black Blood Magnetization Prepared Spiral Fast Spin Echo T1rho Relaxometry for Early Diagnosis of Liver Fibrosis
Liver fibrosis is the main feature in early chronic liver diseases. If identified early, liver fibrosis is reversible. The current gold standard for diagnosing liver fibrosis is invasive liver biopsy. Existing non-invasive methods still have significant limitations.
T1rho imaging is a promising non-invasive technology evaluating liver fibrosis. It does not require exogenous contrast agent or extra hardware. However, it remains challenging to perform T1rho measurements of the liver. The rich blood signal in the liver introduces quantification errors of liver parenchyma. The existing black blood MRI technologies are based on Cartesian FSE acquisitions, which are not optimal for liver imaging. The residual blood signal is often observed which confounds the measurement. Current T1rho measurement of the liver is mostly performed in two-dimension. 3D coverage of liver is desirable. However, 3D T1rho imaging of liver suffers from long scan time due to increased spatial coverage, reduced scan time efficiency from motion compensation, and high specific absorption rate (SAR).
Read more
The investigators aim to overcome these challenges by developing 3D T1rho imaging technologies based on magnetization prepared spiral FSE acquisition. Compared to Cartesian FSE, Spiral FSE traverses k-space more efficiently per unit of time, and has reduced SAR due to significantly decreased number of radiofrequency pulses in the echo trains. Spiral acquisition has zero gradient moment at the kspace center, which substantially reduces its sensitivity to respiratory motion. The residual motion manifests as benign incoherent artifacts in the image domain rather than detrimental structured artifacts. Differently to Cartesian FSE, Spiral FSE provides flexibility to design and optimize flow-sensitizing gradients throughout the echo trains to achieve superior suppression of blood signal. The investigators will evaluate the proposed pulse sequences in both healthy controls and patients with liver fibrosis.
This project will provide new black blood imaging technologies and a 3D diagnostic tool for early detection of liver fibrosis. This will improve clinical outcomes for patients with chronic liver disease, and provide a springboard for further development of MRI technology for other purposes.
- Conditions
- Liver Fibrosis
- Keywords
- 3D, T1rho, Fast spin echo
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with early stage of liver fibrosis | Not described | |
| subjects with no liver fibrosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of variance (ANOVA) will be performed to compare the measurement between subjects with no fibrosis and subjects with early stage fibrosis
Correlations will be calculated to assess the correlation between the disease state determined by histology and the imaging measurements
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Why it stopped: We did not get the grant support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Weitian, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154656
- Sponsor's protocol ID
- 2018.611
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Three-Dimensional Black Blood Magnetization Prepared Spiral Fast Spin Echo T1rho Relaxometry for Early Diagnosis of Liver Fibrosis
- ClinicalTrials.gov ID
- NCT05154656
- Acronym / sponsor ID
- 2018.611
- Conditions
- Liver Fibrosis
- Keywords
- 3D, T1rho, Fast spin echo
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We did not get the grant support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Dec 2021 (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.
Liver fibrosis is the main feature in early chronic liver diseases. If identified early, liver fibrosis is reversible. The current gold standard for diagnosing liver fibrosis is invasive liver biopsy. Existing non-invasive methods still have significant limitations.
T1rho imaging is a promising non-invasive technology evaluating liver fibrosis. It does not require exogenous contrast agent or extra hardware. However, it remains challenging to perform T1rho measurements of the liver. The rich blood signal in the liver introduces quantification errors of liver parenchyma. The existing black blood MRI technologies are based on Cartesian FSE acquisitions, which are not optimal for liver imaging. The residual blood signal is often observed which confounds the measurement. Current T1rho measurement of the liver is mostly performed in two-dimension. 3D coverage of liver is desirable. However, 3D T1rho imaging of liver suffers from long scan time due to increased spatial coverage, reduced scan time efficiency from motion compensation, and high specific absorption rate (SAR).
The investigators aim to overcome these challenges by developing 3D T1rho imaging technologies based on magnetization prepared spiral FSE acquisition. Compared to Cartesian FSE, Spiral FSE traverses k-space more efficiently per unit of time, and has reduced SAR due to significantly decreased number of radiofrequency pulses in the echo trains. Spiral acquisition has zero gradient moment at the kspace center, which substantially reduces its sensitivity to respiratory motion. The residual motion manifests as benign incoherent artifacts in the image domain rather than detrimental structured artifacts. Differently to Cartesian FSE, Spiral FSE provides flexibility to design and optimize flow-sensitizing gradients throughout the echo trains to achieve superior suppression of blood signal. The investigators will evaluate the proposed pulse sequences in both healthy controls and patients with liver fibrosis.
This project will provide new black blood imaging technologies and a 3D diagnostic tool for early detection of liver fibrosis. This will improve clinical outcomes for patients with chronic liver disease, and provide a springboard for further development of MRI technology for other purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with early stage of liver fibrosis | – | – |
| subjects with no liver fibrosis | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 60 patients with early stage of liver fibrosis and 60 subjects with no liver fibrosis
Key inclusion criteria (3 listed)
- Between age 18 and age 55
- patients with early liver fibrosis
- Informed written consent obtained
Key exclusion criteria (1 listed)
- Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of variance (ANOVA) will be performed to compare the measurement between subjects with no fibrosis and subjects with early stage fibrosis
Time frame: one year
Correlations will be calculated to assess the correlation between the disease state determined by histology and the imaging measurements
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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 Fibrosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Sep 2023. 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 Hong Kong. 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 was withdrawn before enrolling participants, so there are no results.
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?
Analysis of variance (ANOVA) will be performed to compare the measurement between subjects with no fibrosis and subjects with early stage fibrosis (time frame: one year). 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 1 Sep 2023.