Fibrosis and Cirrhosis of LiverQMIDLDNCT04626492
Quantitative MRI Imaging in Diffuse Liver Diseases
An observational study of Fibrosis and Cirrhosis of Liver, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
As we all know, the early diagnosis and accurate staging of liver fibrosis are very important to reduce the incidence of liver cirrhosis and liver cancer. And the accurate evaluation of hepatic fibrosis is of great significance to the prediction of residual liver function after liver surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis and Cirrhosis of Liver
- What is being tested?
- Quantitative MRI imaging
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Dec 2022
- How long will I take part?
- 2 Years
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All suspected patients with diffuse liver diseases meet the inclusion criteria will include in this study. And patients who meet the criteria of the normal control group will include in this study
Who may be able to join
- Selection criteria for case group (F1-F4) (meet all the following 1-5 criteria can be selected or only meet the 6 criteria)
- Fatty liver, liver fibrosis or cirrhosis confirmed by clinical, biochemical, imaging examination and liver biopsy;
- no secondary portal hypertension and increase alpha feto protein(AFP);
- no thrombus or plaque in the portal vein and abdominal aorta;
- no history of psychotropic drug addiction;
- MRI examination three days before liver puncture or liver transplantation;
Show all 13Show fewer
- isolated liver of patients undergoing liver transplantation.
- The selection criteria of the normal control group (F0) (meet all the following 1-4 criteria can be selected or only meet the 5 criteria):
- no known acute or chronic liver disease (serologically negative);
- no history of alcoholism, and normal liver function tests;
- no signs of chronic liver disease in CT or MRI;
- no CT or MRI manifestations of focal or diffuse liver disease in the liver;
- abandoned donor liver
Who cannot join
- contraindications for MRI or patients' inability to cooperate with MRI;
- allergy to contrast media and poor image quality can not meet the needs of clinical diagnosis;
- less than 18 years of age, poor quality of liver biopsy;
- renal insufficiency (eGFP < 60ml/min/1.73mm2);
- with severe heart, brain, lung and blood system diseases.
- liver complicated with fulminant liver failure and gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
52 Meihua East Road, New Xiangzhou
Zhuhai, Guangdong, 519000
Yujuan Qin, Master, 0086 756 2528321, qinyj5@mail.sysu.edu.cn
Shaolin Li, Doctor, 0086 756 2528321, lishaolin1963@126.com
About this study
Official title: Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases
As we all know, the early diagnosis and accurate staging of liver fibrosis are very important to reduce the incidence of liver cirrhosis and liver cancer. And the accurate evaluation of hepatic fibrosis is of great significance to the prediction of residual liver function after liver surgery. Therefore, clinicians pay more and more attention to the qualitative and quantitative diagnosis of hepatic fibrosis, liver cirrhosis and hepatic steatosis involved in diffuse liver diseases(such as fatty liver, viral hepatitis, autoimmune hepatitis ). And now, liver biopsy is commonly used as the gold standard for the evaluation of steatohepatitis and fibrosis. However, this test is invasive, has low patient acceptance. So more and more clinicians recommend non-invasive methods to qualitatively and quantitatively evaluate the liver steatosis, fibrosis and cirrhosis in diffuse liver diseases. At present, serum markers, ultrasonic elastography and magnetic resonance imaging have good accuracy in the non-invasive detection and evaluation of liver cirrhosis. However, serum markers are not liver-specific, and a single serum marker is not enough to accurately reflect the degree of liver fibrosis. Furthermore, whether the non-invasive liver fiber diagnostic model is suitable for patients with liver disease in China remains to be further verified. At present, transient elastography has been recommended for the non-invasive staging of hepatic fibrosis by the clinical practice guidelines of the European Association for liver Research and the Asia-Pacific Association for liver Research. But as serum markers, it still has low sensitivity and specificity in the diagnosis of early hepatic fibrosis, and is highly operationally dependent. With the development of MRI technology, some MRI quantitative techniques, such as T1mapping, T2mapping,Intravoxel incoherent motion diffusion-weighted magnetic resonance imaging(IVIM-DWI), dynamic contrast enhanced magnetic resonance imaging(DCE-MRI) can be used to qualitatively and quantitatively diagnosis of liver fat, hepatic fibrosis and cirrhosis. And iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence(IDEALIQ) usually used to evaluate liver fat. The existing research results showed that MRI quantitative techniques has a high value in quantitative diagnosis of advanced hepatic fibrosis and cirrhosis. But it still has some limitations in quantitative diagnosis of early liver fibrosis. And what's more,some of the research results still can not reach a consensus. Therefore, based on the multi-parameter potential of MRI and the characteristics of metabolic evaluation. This study will adjust some of the parameters of MRI quantitative techniques, and through large sample datas, combined with a variety of quantitative techniques to explore the application value of MRI quantitative techniques in the quantitative diagnosis of liver diffuse lesions, especially in the early stage of liver fibrosis.
- Conditions
- Fibrosis and Cirrhosis of Liver
- Being tested
- Quantitative MRI imaging
- Keywords
- Magnetic resonance imaging, Fatty liver, Liver Steatosis, Steatohepatitis, Liver Fibrosis, Hepatic Cirrhosis, Dynamic contrast enhanced magnetic resonance imaging
- Medical subject headings
- Fibrosis, Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative MRI imagingDiagnostic test
Dynamic contrast enhanced magnetic resonance imaging,Intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging,Iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence
| Study group | Role | What they receive |
|---|---|---|
| F0 | Normal control group Receives: Diagnostic Test: Quantitative MRI imaging | |
| F1 | Grade 1 of liver fibrosis Receives: Diagnostic Test: Quantitative MRI imaging | |
| F2 | Grade 2 of liver fibrosis Receives: Diagnostic Test: Quantitative MRI imaging | |
| F3 | Grade 3 of liver fibrosis Receives: Diagnostic Test: Quantitative MRI imaging | |
| F4 | Hepatic cirrhosis Receives: Diagnostic Test: Quantitative MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative MRI imaging diagnose diffuse hepatic lesions
Quantitative MRI imaging(such as dynamic contrast enhanced magnetic, intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging resonance imaging, Intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging, Iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence) used to quantitative diagnosis of fatty liver hepatitis, liver fibrosis, cirrhosis, etc.
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 Nov 2020
- Study start1 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Fibrosis and Cirrhosis of LiverStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShaoLin Li, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shaolin Li, Director, Principal investigator, Radiology Department，the Fifth Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626492
- Sponsor's protocol ID
- ZDWY.FSK.005
- Acronym
- QMIDLD
- Status last verified
- Feb 2021
- First submitted
- 10 Nov 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan JG, Kim SU, Wong VW. New trends on obesity and NAFLD in Asia. J Hepatol. 2017 Oct;67(4):862-873. doi: 10.1016/j.jhep.2017.06.003. Epub 2017 Jun 19.
PubMed 28642059Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic Steatohepatitis: A Review. JAMA. 2020 Mar 24;323(12):1175-1183. doi: 10.1001/jama.2020.2298.
PubMed 32207804Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.
PubMed 21440669Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin Gastroenterol Hepatol. 2012 Jun;10(6):657-63.e7. doi: 10.1016/j.cgh.2012.01.023. Epub 2012 Feb 14.
PubMed 22343514Dong XQ, Wu Z, Zhao H, Wang GQ; China HepB-Related Fibrosis Assessment Research Group. Evaluation and comparison of thirty noninvasive models for diagnosing liver fibrosis in chinese hepatitis B patients. J Viral Hepat. 2019 Feb;26(2):297-307. doi: 10.1111/jvh.13031. Epub 2018 Nov 28.
PubMed 30380170Wai CT, Greenson JK, Fontana RJ, Kalbfleisch JD, Marrero JA, Conjeevaram HS, Lok AS. A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology. 2003 Aug;38(2):518-26. doi: 10.1053/jhep.2003.50346.
PubMed 12883497Thiele M, Detlefsen S, Sevelsted Moller L, Madsen BS, Fuglsang Hansen J, Fialla AD, Trebicka J, Krag A. Transient and 2-Dimensional Shear-Wave Elastography Provide Comparable Assessment of Alcoholic Liver Fibrosis and Cirrhosis. Gastroenterology. 2016 Jan;150(1):123-33. doi: 10.1053/j.gastro.2015.09.040. Epub 2015 Oct 3.
PubMed 26435270Wu S, Yang Z, Zhou J, Zeng N, He Z, Zhan S, Jia J, You H. Systematic review: diagnostic accuracy of non-invasive tests for staging liver fibrosis in autoimmune hepatitis. Hepatol Int. 2019 Jan;13(1):91-101. doi: 10.1007/s12072-018-9907-5. Epub 2018 Nov 15.
PubMed 30443702Zhang YN, Fowler KJ, Hamilton G, Cui JY, Sy EZ, Balanay M, Hooker JC, Szeverenyi N, Sirlin CB. Liver fat imaging-a clinical overview of ultrasound, CT, and MR imaging. Br J Radiol. 2018 Sep;91(1089):20170959. doi: 10.1259/bjr.20170959. Epub 2018 Jun 6.
PubMed 29722568Singh S, Venkatesh SK, Wang Z, Miller FH, Motosugi U, Low RN, Hassanein T, Asbach P, Godfrey EM, Yin M, Chen J, Keaveny AP, Bridges M, Bohte A, Murad MH, Lomas DJ, Talwalkar JA, Ehman RL. Diagnostic performance of magnetic resonance elastography in staging liver fibrosis: a systematic review and meta-analysis of individual participant data. Clin Gastroenterol Hepatol. 2015 Mar;13(3):440-451.e6. doi: 10.1016/j.cgh.2014.09.046. Epub 2014 Nov 20.
PubMed 25305349Li Z, Sun J, Chen L, Huang N, Hu P, Hu X, Han G, Zhou Y, Bai W, Niu T, Yang X. Assessment of liver fibrosis using pharmacokinetic parameters of dynamic contrast-enhanced magnetic resonance imaging. J Magn Reson Imaging. 2016 Jul;44(1):98-104. doi: 10.1002/jmri.25132. Epub 2015 Dec 28.
PubMed 26707910Wu CH, Ho MC, Jeng YM, Liang PC, Hu RH, Lai HS, Shih TT. Assessing hepatic fibrosis: comparing the intravoxel incoherent motion in MRI with acoustic radiation force impulse imaging in US. Eur Radiol. 2015 Dec;25(12):3552-9. doi: 10.1007/s00330-015-3774-4. Epub 2015 May 20.
PubMed 25991478Li J, Liu H, Zhang C, Yang S, Wang Y, Chen W, Li X, Wang D. Native T1 mapping compared to ultrasound elastography for staging and monitoring liver fibrosis: an animal study of repeatability, reproducibility, and accuracy. Eur Radiol. 2020 Jan;30(1):337-345. doi: 10.1007/s00330-019-06335-0. Epub 2019 Jul 23.
PubMed 31338650Hoffman DH, Ayoola A, Nickel D, Han F, Chandarana H, Shanbhogue KP. T1 mapping, T2 mapping and MR elastography of the liver for detection and staging of liver fibrosis. Abdom Radiol (NY). 2020 Mar;45(3):692-700. doi: 10.1007/s00261-019-02382-9.
PubMed 31875241Loomba R, Neuschwander-Tetri BA, Sanyal A, Chalasani N, Diehl AM, Terrault N, Kowdley K, Dasarathy S, Kleiner D, Behling C, Lavine J, Van Natta M, Middleton M, Tonascia J, Sirlin C; NASH Clinical Research Network. Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH. Hepatology. 2020 Oct;72(4):1219-1229. doi: 10.1002/hep.31121. Epub 2020 Oct 9.
PubMed 31965579
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases
- ClinicalTrials.gov ID
- NCT04626492
- Acronym / sponsor ID
- QMIDLD / ZDWY.FSK.005
- Conditions
- Fibrosis and Cirrhosis of Liver
- Keywords
- Magnetic resonance imaging, Fatty liver, Liver Steatosis, Steatohepatitis, Liver Fibrosis, Hepatic Cirrhosis, Dynamic contrast enhanced magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Nov 2020 (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.
As we all know, the early diagnosis and accurate staging of liver fibrosis are very important to reduce the incidence of liver cirrhosis and liver cancer. And the accurate evaluation of hepatic fibrosis is of great significance to the prediction of residual liver function after liver surgery. Therefore, clinicians pay more and more attention to the qualitative and quantitative diagnosis of hepatic fibrosis, liver cirrhosis and hepatic steatosis involved in diffuse liver diseases(such as fatty liver, viral hepatitis, autoimmune hepatitis ). And now, liver biopsy is commonly used as the gold standard for the evaluation of steatohepatitis and fibrosis. However, this test is invasive, has low patient acceptance. So more and more clinicians recommend non-invasive methods to qualitatively and quantitatively evaluate the liver steatosis, fibrosis and cirrhosis in diffuse liver diseases. At present, serum markers, ultrasonic elastography and magnetic resonance imaging have good accuracy in the non-invasive detection and evaluation of liver cirrhosis. However, serum markers are not liver-specific, and a single serum marker is not enough to accurately reflect the degree of liver fibrosis. Furthermore, whether the non-invasive liver fiber diagnostic model is suitable for patients with liver disease in China remains to be further verified. At present, transient elastography has been recommended for the non-invasive staging of hepatic fibrosis by the clinical practice guidelines of the European Association for liver Research and the Asia-Pacific Association for liver Research. But as serum markers, it still has low sensitivity and specificity in the diagnosis of early hepatic fibrosis, and is highly operationally dependent. With the development of MRI technology, some MRI quantitative techniques, such as T1mapping, T2mapping,Intravoxel incoherent motion diffusion-weighted magnetic resonance imaging(IVIM-DWI), dynamic contrast enhanced magnetic resonance imaging(DCE-MRI) can be used to qualitatively and quantitatively diagnosis of liver fat, hepatic fibrosis and cirrhosis. And iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence(IDEALIQ) usually used to evaluate liver fat. The existing research results showed that MRI quantitative techniques has a high value in quantitative diagnosis of advanced hepatic fibrosis and cirrhosis. But it still has some limitations in quantitative diagnosis of early liver fibrosis. And what's more,some of the research results still can not reach a consensus. Therefore, based on the multi-parameter potential of MRI and the characteristics of metabolic evaluation. This study will adjust some of the parameters of MRI quantitative techniques, and through large sample datas, combined with a variety of quantitative techniques to explore the application value of MRI quantitative techniques in the quantitative diagnosis of liver diffuse lesions, especially in the early stage of liver fibrosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| F0 | – | Diagnostic Test: Quantitative MRI imagingNormal control group |
| F1 | – | Diagnostic Test: Quantitative MRI imagingGrade 1 of liver fibrosis |
| F2 | – | Diagnostic Test: Quantitative MRI imagingGrade 2 of liver fibrosis |
| F3 | – | Diagnostic Test: Quantitative MRI imagingGrade 3 of liver fibrosis |
| F4 | – | Diagnostic Test: Quantitative MRI imagingHepatic cirrhosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All suspected patients with diffuse liver diseases meet the inclusion criteria will include in this study. And patients who meet the criteria of the normal control group will include in this study
Key inclusion criteria (13 listed)
- Selection criteria for case group (F1-F4) (meet all the following 1-5 criteria can be selected or only meet the 6 criteria)
- Fatty liver, liver fibrosis or cirrhosis confirmed by clinical, biochemical, imaging examination and liver biopsy;
- no secondary portal hypertension and increase alpha feto protein(AFP);
- no thrombus or plaque in the portal vein and abdominal aorta;
- no history of psychotropic drug addiction;
Key exclusion criteria (6 listed)
- contraindications for MRI or patients' inability to cooperate with MRI;
- allergy to contrast media and poor image quality can not meet the needs of clinical diagnosis;
- less than 18 years of age, poor quality of liver biopsy;
- renal insufficiency (eGFP < 60ml/min/1.73mm2);
- with severe heart, brain, lung and blood system diseases.
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 |
|---|---|---|
| Quantitative MRI imagingDynamic contrast enhanced magnetic resonance imaging,Intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging,Iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence | Diagnostic test | F0, F1, F2, F3, F4 |
Primary outcome
Quantitative MRI imaging diagnose diffuse hepatic lesions
Time frame: 2 years
Quantitative MRI imaging(such as dynamic contrast enhanced magnetic, intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging resonance imaging, Intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging, Iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence) used to quantitative diagnosis of fatty liver hepatitis, liver fibrosis, cirrhosis, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 28642059Fan JG, Kim SU, Wong VW. New trends on obesity and NAFLD in Asia. J Hepatol. 2017 Oct;67(4):862-873. doi: 10.1016/j.jhep.2017.06.003. Epub 2017 Jun 19.
- Background: PubMed 32207804Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic Steatohepatitis: A Review. JAMA. 2020 Mar 24;323(12):1175-1183. doi: 10.1001/jama.2020.2298.
- Background: PubMed 21440669Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.
- Background: PubMed 22343514Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin Gastroenterol Hepatol. 2012 Jun;10(6):657-63.e7. doi: 10.1016/j.cgh.2012.01.023. Epub 2012 Feb 14.
- Background: PubMed 30380170Dong XQ, Wu Z, Zhao H, Wang GQ; China HepB-Related Fibrosis Assessment Research Group. Evaluation and comparison of thirty noninvasive models for diagnosing liver fibrosis in chinese hepatitis B patients. J Viral Hepat. 2019 Feb;26(2):297-307. doi: 10.1111/jvh.13031. Epub 2018 Nov 28.
- Background: PubMed 12883497Wai CT, Greenson JK, Fontana RJ, Kalbfleisch JD, Marrero JA, Conjeevaram HS, Lok AS. A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology. 2003 Aug;38(2):518-26. doi: 10.1053/jhep.2003.50346.
- Background: PubMed 26435270Thiele M, Detlefsen S, Sevelsted Moller L, Madsen BS, Fuglsang Hansen J, Fialla AD, Trebicka J, Krag A. Transient and 2-Dimensional Shear-Wave Elastography Provide Comparable Assessment of Alcoholic Liver Fibrosis and Cirrhosis. Gastroenterology. 2016 Jan;150(1):123-33. doi: 10.1053/j.gastro.2015.09.040. Epub 2015 Oct 3.
- Background: PubMed 30443702Wu S, Yang Z, Zhou J, Zeng N, He Z, Zhan S, Jia J, You H. Systematic review: diagnostic accuracy of non-invasive tests for staging liver fibrosis in autoimmune hepatitis. Hepatol Int. 2019 Jan;13(1):91-101. doi: 10.1007/s12072-018-9907-5. Epub 2018 Nov 15.
- Background: PubMed 29722568Zhang YN, Fowler KJ, Hamilton G, Cui JY, Sy EZ, Balanay M, Hooker JC, Szeverenyi N, Sirlin CB. Liver fat imaging-a clinical overview of ultrasound, CT, and MR imaging. Br J Radiol. 2018 Sep;91(1089):20170959. doi: 10.1259/bjr.20170959. Epub 2018 Jun 6.
- Background: PubMed 25305349Singh S, Venkatesh SK, Wang Z, Miller FH, Motosugi U, Low RN, Hassanein T, Asbach P, Godfrey EM, Yin M, Chen J, Keaveny AP, Bridges M, Bohte A, Murad MH, Lomas DJ, Talwalkar JA, Ehman RL. Diagnostic performance of magnetic resonance elastography in staging liver fibrosis: a systematic review and meta-analysis of individual participant data. Clin Gastroenterol Hepatol. 2015 Mar;13(3):440-451.e6. doi: 10.1016/j.cgh.2014.09.046. Epub 2014 Nov 20.
- Background: PubMed 26707910Li Z, Sun J, Chen L, Huang N, Hu P, Hu X, Han G, Zhou Y, Bai W, Niu T, Yang X. Assessment of liver fibrosis using pharmacokinetic parameters of dynamic contrast-enhanced magnetic resonance imaging. J Magn Reson Imaging. 2016 Jul;44(1):98-104. doi: 10.1002/jmri.25132. Epub 2015 Dec 28.
- Background: PubMed 25991478Wu CH, Ho MC, Jeng YM, Liang PC, Hu RH, Lai HS, Shih TT. Assessing hepatic fibrosis: comparing the intravoxel incoherent motion in MRI with acoustic radiation force impulse imaging in US. Eur Radiol. 2015 Dec;25(12):3552-9. doi: 10.1007/s00330-015-3774-4. Epub 2015 May 20.
- 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.
Shaolin Li, Director principal investigator
Radiology Department，the Fifth Affiliated Hospital of Sun Yat-sen University
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 Fibrosis and Cirrhosis of Liver, run by Fifth Affiliated Hospital, Sun Yat-Sen University 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 13 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 21 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 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?
Contact Yujuan Qin, Master (0086 756 2528321, qinyj5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative MRI imaging diagnose diffuse hepatic lesions (time frame: 2 years). 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 NCT04626492, which also lists 15 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 21 Feb 2021.