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Liver FibrosisFULLFIBRO01NCT03293953

Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

An observational study of Liver Fibrosis, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Liver Fibrosis
How many people
100 participants
Where
1 siteItaly
Study dates
1 May 2017to 1 Nov 2018
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV)

Who may be able to join

  • enrollment of a consecutive cohort of at least 100 patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV).

Who cannot join

  • contraindications to undergo MRI examination. Impossibility to obtain a valid TE measurement (e.g. narrow intercostal spaces; obese patients)

Trial locations and contacts

1 site in 1 country.

Gian Andrea Rollandi, MD contact

0039010563 ext. 4810

gianandrea.rollandi@galliera.it

Alessandra Argusti, PhD contact

0039010563 ext. 4188

alessandra.argusti@galliera.it

Italy1 site, 1 recruiting

  • SC Radiodiagnostica

    Genova, 16128

    Gian Andrea Rollandi, MD, 0039010563 ext. 4810, gianandrea.rollandi@galliera.it

    Alessandra Argusti, PhD, 0039010563 ext. 4188, alessandra.argusti@galliera.it

    Recruiting

Other trials in Italy

About this study

Official title: Prospective Comparison Between Transient Elastography (TE), Shear Wave Elastography (SWE) and Magnetic Resonance Elastography (MRE) for Non-invasive Assessment of Liver Fibrosis in Patients Affected by Chronic Viral Hepatitis

The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Read the detailed description

Primary Endpoint: Verify if Transient Elastography, Shear Wave Elastography, Magnetic Resonance Elastography (MRE) get comparable results in the measurement of liver fibrosis Secondary Endpoint: To evaluate if the level of liver iron overload and steatosis may act as a confounding factor in stiffness measurements by MRE.

Tertiary Endpoint: to provide information about the prevalence and grade of steatosis in a consecutive cohort of patients with chronic viral C hepatitis, and to verify if the presence and grade of parenchymal steatosis may affect the correlation between the different non-invasive stiffness imaging modalities.

Subject: consecutive 100 patients affected by chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Conditions
Liver Fibrosis
Keywords
HCV, HIV, Liver Fibrosis, Liver Iron Overload
Medical subject headings
Liver Cirrhosis

What is being measured

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

  1. liver stiffness

    liver stiffness is indicated in kPa

    Measured: 18 months

Secondary outcomes (2)

  1. liver iron overload

    liver iron concentration (LIC) is indicated in mg/g dw

    Measured: 18 months

  2. liver steatosis

    liver steatosis

    Measured: 18 months

Timeline

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

  1. First posted26 Sep 2017
  2. Study start1 May 2017
  3. Primary completion1 Nov 2018 (estimated)
  4. Study completion1 Nov 2018 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03293953
Sponsor's protocol ID
41UCS2016
Acronym
FULLFIBRO01
Status last verified
Sep 2017
First submitted
21 Sep 2017
Last updated
26 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.

    PubMed 19330875

  • Castera L. Invasive and non-invasive methods for the assessment of fibrosis and disease progression in chronic liver disease. Best Pract Res Clin Gastroenterol. 2011 Apr;25(2):291-303. doi: 10.1016/j.bpg.2011.02.003.

    PubMed 21497746

  • Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.

    PubMed 11172192

  • Regev A, Berho M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002 Oct;97(10):2614-8. doi: 10.1111/j.1572-0241.2002.06038.x.

    PubMed 12385448

  • Baranova A, Lal P, Birerdinc A, Younossi ZM. Non-invasive markers for hepatic fibrosis. BMC Gastroenterol. 2011 Aug 17;11:91. doi: 10.1186/1471-230X-11-91.

    PubMed 21849046

  • Paparo F, Corradi F, Cevasco L, Revelli M, Marziano A, Molini L, Cenderello G, Cassola G, Rollandi GA. Real-time elastography in the assessment of liver fibrosis: a review of qualitative and semi-quantitative methods for elastogram analysis. Ultrasound Med Biol. 2014 Sep;40(9):1923-33. doi: 10.1016/j.ultrasmedbio.2014.03.021. Epub 2014 Jun 25.

    PubMed 24972497

  • Tang A, Cloutier G, Szeverenyi NM, Sirlin CB. Ultrasound Elastography and MR Elastography for Assessing Liver Fibrosis: Part 1, Principles and Techniques. AJR Am J Roentgenol. 2015 Jul;205(1):22-32. doi: 10.2214/AJR.15.14552. Epub 2015 Apr 23.

    PubMed 25905647

  • Ferraioli G, Tinelli C, Lissandrin R, Zicchetti M, Dal Bello B, Filice G, Filice C. Point shear wave elastography method for assessing liver stiffness. World J Gastroenterol. 2014 Apr 28;20(16):4787-96. doi: 10.3748/wjg.v20.i16.4787.

    PubMed 24782633

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011 Aug;55(2):245-64. doi: 10.1016/j.jhep.2011.02.023. Epub 2011 Mar 1. No abstract available.

    PubMed 21371579

  • Tang A, Cloutier G, Szeverenyi NM, Sirlin CB. Ultrasound Elastography and MR Elastography for Assessing Liver Fibrosis: Part 2, Diagnostic Performance, Confounders, and Future Directions. AJR Am J Roentgenol. 2015 Jul;205(1):33-40. doi: 10.2214/AJR.15.14553. Epub 2015 Apr 23.

    PubMed 25905762

  • Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Ledinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. doi: 10.1002/hep.20506.

    PubMed 15690481

  • Yoon JH, Lee JM, Joo I, Lee ES, Sohn JY, Jang SK, Lee KB, Han JK, Choi BI. Hepatic fibrosis: prospective comparison of MR elastography and US shear-wave elastography for evaluation. Radiology. 2014 Dec;273(3):772-82. doi: 10.1148/radiol.14132000. Epub 2014 Jul 7.

    PubMed 25007047

  • Bohte AE, de Niet A, Jansen L, Bipat S, Nederveen AJ, Verheij J, Terpstra V, Sinkus R, van Nieuwkerk KM, de Knegt RJ, Baak BC, Jansen PL, Reesink HW, Stoker J. Non-invasive evaluation of liver fibrosis: a comparison of ultrasound-based transient elastography and MR elastography in patients with viral hepatitis B and C. Eur Radiol. 2014 Mar;24(3):638-48. doi: 10.1007/s00330-013-3046-0. Epub 2013 Oct 25.

    PubMed 24158528

  • Paparo F, Cenderello G, Revelli M, Bacigalupo L, Rutigliani M, Zefiro D, Cevasco L, Amico M, Bandelloni R, Cassola G, Forni GL, Rollandi GA. Diagnostic value of MRI proton density fat fraction for assessing liver steatosis in chronic viral C hepatitis. Biomed Res Int. 2015;2015:758164. doi: 10.1155/2015/758164. Epub 2015 Mar 19.

    PubMed 25866807

  • Negro F. Mechanisms and significance of liver steatosis in hepatitis C virus infection. World J Gastroenterol. 2006 Nov 14;12(42):6756-65. doi: 10.3748/wjg.v12.i42.6756.

    PubMed 17106922

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Fibrosis, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.

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 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2017. 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 Italy. 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 Gian Andrea Rollandi, MD (0039010563 ext. 4810, gianandrea.rollandi@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

liver stiffness (time frame: 18 months). 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 NCT03293953, which also lists 20 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 26 Sep 2017.

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