Quantitative MRI Imaging in Diffuse Liver Diseases

NCT ID: NCT04626492

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fibrosis and Cirrhosis of Liver

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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F0

Normal control group

Quantitative MRI imaging

Intervention Type DIAGNOSTIC_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

F1

Grade 1 of liver fibrosis

Quantitative MRI imaging

Intervention Type DIAGNOSTIC_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

F2

Grade 2 of liver fibrosis

Quantitative MRI imaging

Intervention Type DIAGNOSTIC_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

F3

Grade 3 of liver fibrosis

Quantitative MRI imaging

Intervention Type DIAGNOSTIC_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

F4

Hepatic cirrhosis

Quantitative MRI imaging

Intervention Type DIAGNOSTIC_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

Interventions

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Quantitative MRI imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Selection criteria for case group (F1-F4) (meet all the following 1-5 criteria can be selected or only meet the 6 criteria)

1. Fatty liver, liver fibrosis or cirrhosis confirmed by clinical, biochemical, imaging examination and liver biopsy;
2. no secondary portal hypertension and increase alpha feto protein(AFP);
3. no thrombus or plaque in the portal vein and abdominal aorta;
4. no history of psychotropic drug addiction;
5. MRI examination three days before liver puncture or liver transplantation;
6. 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):

1. no known acute or chronic liver disease (serologically negative);
2. no history of alcoholism, and normal liver function tests;
3. no signs of chronic liver disease in CT or MRI;
4. no CT or MRI manifestations of focal or diffuse liver disease in the liver;
5. abandoned donor liver

Exclusion Criteria

1. contraindications for MRI or patients' inability to cooperate with MRI;
2. allergy to contrast media and poor image quality can not meet the needs of clinical diagnosis;
3. less than 18 years of age, poor quality of liver biopsy;
4. renal insufficiency (eGFP \< 60ml/min/1.73mm2);
5. with severe heart, brain, lung and blood system diseases.
6. liver complicated with fulminant liver failure and gastrointestinal bleeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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ShaoLin Li

Director of Radiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaolin Li, Director

Role: PRINCIPAL_INVESTIGATOR

Radiology Department,the Fifth Affiliated Hospital of Sun Yat-sen University

Locations

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52 Meihua East Road, New Xiangzhou

Zhuhai, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yujuan Qin, Master

Role: CONTACT

0086 756 2528321

Shaolin Li, Director

Role: CONTACT

0086 756 2528321

Facility Contacts

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Yujuan Qin, Master

Role: primary

0086 756 2528321

Shaolin Li, Doctor

Role: backup

0086 756 2528321

References

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Reference Type BACKGROUND
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Dong 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.

Reference Type BACKGROUND
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Wai 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.

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Thiele 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.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Singh 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.

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Li 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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Li 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.

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Hoffman 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.

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Reference Type BACKGROUND
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Other Identifiers

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ZDWY.FSK.005

Identifier Type: -

Identifier Source: org_study_id

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