AzTrials
AzTrials

Liver FibrosisNCT03176797

Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

A study testing Liver MRI in people with Liver Fibrosis and Cirrhosis, run by Zhujiang Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Liver Fibrosis, Cirrhosis
What is being tested?
Liver MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
3 May 2017to 31 Dec 2025
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
  • AND willingly able to complete all research procedures and follow the entire research process
  • AND scheduled for liver resection or biopsy
  • AND signed informed consent

Who cannot join

  • Any contraindication for contrast-enhanced MRI
  • Pregnant or nursing women
  • Any organ transplant history, and existing functional grafts (except corneal or fur grafts)
  • Recent right upper quadrant patients with traumatic healed
  • A serious history of illness or other evidence of a serious illness or suffering from any other disease
  • Patients who have been enrolled in other interventional clinical trials

Trial locations and contacts

1 site in 1 country.

China1 site

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

Other trials in China

About this study

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

Read the detailed description

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

Being tested
Liver MRI
Keywords
Liver Fibrosis, multiparametric magnetic resonance imaging
Medical subject headings
Liver Cirrhosis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver MRIDiagnostic test

    Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.

Study groups in NCT03176797
Study groupRoleWhat they receive
Liver MRIExperimentalLiver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.
Receives: Diagnostic Test: Liver MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI T1ρ T1mapping SWI and DWI

    Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology

    Measured: MRI within 3 months of liver biopsy or surgery

Secondary outcomes (1)

  1. MRI T1ρ T1mapping SWI and DWI

    Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers.

    Measured: Blood Test taken on same day as MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study start3 May 2017
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03176797
Sponsor's protocol ID
LC2016PY034
Status last verified
Mar 2024
First submitted
1 Jun 2017
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kobayashi K, Nakao H, Nishiyama T, Lin Y, Kikuchi S, Kobayashi Y, Yamamoto T, Ishii N, Ohashi T, Satoh K, Nakade Y, Ito K, Yoneda M. Diagnostic accuracy of real-time tissue elastography for the staging of liver fibrosis: a meta-analysis. Eur Radiol. 2015 Jan;25(1):230-8. doi: 10.1007/s00330-014-3364-x. Epub 2014 Aug 23.

    PubMed 25149296

  • Friedrich-Rust M, Rosenberg W, Parkes J, Herrmann E, Zeuzem S, Sarrazin C. Comparison of ELF, FibroTest and FibroScan for the non-invasive assessment of liver fibrosis. BMC Gastroenterol. 2010 Sep 9;10:103. doi: 10.1186/1471-230X-10-103.

    PubMed 20828377

  • Wang YX, Yuan J, Chu ES, Go MY, Huang H, Ahuja AT, Sung JJ, Yu J. T1rho MR imaging is sensitive to evaluate liver fibrosis: an experimental study in a rat biliary duct ligation model. Radiology. 2011 Jun;259(3):712-9. doi: 10.1148/radiol.11101638. Epub 2011 Mar 24.

    PubMed 21436087

  • Zhao F, Wang YX, Yuan J, Deng M, Wong HL, Chu ES, Go MY, Teng GJ, Ahuja AT, Yu J. MR T1rho as an imaging biomarker for monitoring liver injury progression and regression: an experimental study in rats with carbon tetrachloride intoxication. Eur Radiol. 2012 Aug;22(8):1709-16. doi: 10.1007/s00330-012-2419-0. Epub 2012 Mar 27.

    PubMed 22752522

  • Girometti R, Furlan A, Esposito G, Bazzocchi M, Como G, Soldano F, Isola M, Toniutto P, Zuiani C. Relevance of b-values in evaluating liver fibrosis: a study in healthy and cirrhotic subjects using two single-shot spin-echo echo-planar diffusion-weighted sequences. J Magn Reson Imaging. 2008 Aug;28(2):411-9. doi: 10.1002/jmri.21461.

    PubMed 18666139

  • Hu G, Chan Q, Quan X, Zhang X, Li Y, Zhong X, Lin X. Intravoxel incoherent motion MRI evaluation for the staging of liver fibrosis in a rat model. J Magn Reson Imaging. 2015 Aug;42(2):331-9. doi: 10.1002/jmri.24796. Epub 2014 Nov 11.

    PubMed 25384923

  • Shiha G, Ibrahim A, Helmy A, Sarin SK, Omata M, Kumar A, Bernstien D, Maruyama H, Saraswat V, Chawla Y, Hamid S, Abbas Z, Bedossa P, Sakhuja P, Elmahatab M, Lim SG, Lesmana L, Sollano J, Jia JD, Abbas B, Omar A, Sharma B, Payawal D, Abdallah A, Serwah A, Hamed A, Elsayed A, AbdelMaqsod A, Hassanein T, Ihab A, GHaziuan H, Zein N, Kumar M. Asian-Pacific Association for the Study of the Liver (APASL) consensus guidelines on invasive and non-invasive assessment of hepatic fibrosis: a 2016 update. Hepatol Int. 2017 Jan;11(1):1-30. doi: 10.1007/s12072-016-9760-3. Epub 2016 Oct 6.

    PubMed 27714681

  • Petitclerc L, Sebastiani G, Gilbert G, Cloutier G, Tang A. Liver fibrosis: Review of current imaging and MRI quantification techniques. J Magn Reson Imaging. 2017 May;45(5):1276-1295. doi: 10.1002/jmri.25550. Epub 2016 Dec 16.

    PubMed 27981751

  • Hu G, Zhang X, Liang W, Zhong X, Chan Q, Lin X, Lin T, Li Y, Quan X. Assessment of liver fibrosis in rats by MRI with apparent diffusion coefficient and T1 relaxation time in the rotating frame. J Magn Reson Imaging. 2016 May;43(5):1082-9. doi: 10.1002/jmri.25084. Epub 2015 Oct 26.

    PubMed 26497954

Questions about this trial

What is this clinical trial studying?

A study testing Liver MRI in people with Liver Fibrosis and Cirrhosis, run by Zhujiang Hospital at 1 site in China.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 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 China. 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?

Results are not available in the source record.

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?

MRI T1ρ T1mapping SWI and DWI (time frame: MRI within 3 months of liver biopsy or surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03176797, which also lists 9 linked publications.

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 15 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in