Utility of Fibroscan in Estimating Hepatic Iron Concentration

NCT02067130 | Unknown

• 1 other identifier: H13-02149
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with hereditary anemias (e.g. thalassemias), defective red blood cells are produced due to an error in the genes, or DNA, that provide the instructions for their synthesis. As a result, hereditary anemias are characterized by chronically low hemoglobin, which is contained inside red blood cells and carries oxygen throughout the body. In more severe cases, patients are dependent on frequent blood transfusions to replenish the hemoglobin. The body has limited ability to get rid of excess iron. However, with repeated blood transfusions, the iron level in the body builds up because the red blood cells contain iron as heme. Over time, the high level of iron accumulates in organs such as the heart, liver, and pancreas causing heart problems, liver failure, and diabetes. As a result, patients who receive multiple blood transfusions need to be monitored for iron overload, and be started on medical therapy in a timely fashion to prevent organ damage. Liver is usually the first and the most affected organ by iron accumulation, so knowledge of its iron concentration provides estimate of total body iron load. Liver biopsy is the gold standard in measuring the iron concentration in the liver, but it is invasive and cannot be performed on routine basis. MRI is another option that can assess liver iron concentration non-invasively, and is currently recommended for monitoring iron load on a yearly basis. However, MRI has a high cost and is not easily accessible in Canada. The investigators aim to determine if transient elastography (Fibroscan), which is a form of ultrasound that measures liver stiffness, can accurately assess liver iron concentration. Hypothesis: Fibroscan reading correlates with MRI and serum ferritin in estimating hepatic iron concentration.

Conditions

Hereditary Anemias

Keywords

Beta Thalassemia Major

Outcome Measures

Primary Outcomes (1)

• Fibroscan reading collected at the Gastroenterologist's outpatient clinic

  Fibroscan results will be compared to that of T2\* MRI, R2 MRI (FerriScan) and serum ferritin using linear regression models to determine if there is any correlation between FibroScan® results and liver iron concentration, which is indirectly measured with MRI and serum ferritin.

  1 year

Study Arms (1)

Fibroscan

OTHER

Subjects enrolled will undergo Fibroscan. It is an affordable and noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis. Fibroscan reading will be collected at the Gastroenterologist's (Dr. Ko) outpatient clinic (Pacific Gastroenterology Associates) where a qualified research nurse/assistant will perform the scan under supervision of the physician. Anticipated timing of this procedure will be October to December 2013

Procedure: Fibroscan

Interventions

Fibroscan PROCEDURE

Transient elastography (Fibroscan®) is an affordable and noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis. Since Fibroscan® measures liver's stiffness, its utility is not limited to fibrosis, and has been extended to other conditions that would increase the liver's stiffness, such as amyloidosis (Loustaud-Ratti et al. Amyloid 2011) and perhaps iron overload.

Fibroscan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients (age 19 or greater) with hereditary anemias requiring chronic blood transfusion at St. Paul's Hospital will be invited to participate in this study. The majority of patients will be β-Thalassemia Major.

You may not qualify if:

• Known Hepatitis B positive
• Known Hepatitis C positive
• Known HIV positive
• Known liver cirrhosis
• Known primary liver disease such as Wilson's disease and hereditary hemochromatosis

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (7)

• Shander A, Sazama K. Clinical consequences of iron overload from chronic red blood cell transfusions, its diagnosis, and its management by chelation therapy. Transfusion. 2010 May;50(5):1144-55. doi: 10.1111/j.1537-2995.2009.02551.x. Epub 2010 Jan 15.

  PMID: 20088842 BACKGROUND

• Jung KS, Kim SU. Clinical applications of transient elastography. Clin Mol Hepatol. 2012 Jun;18(2):163-73. doi: 10.3350/cmh.2012.18.2.163. Epub 2012 Jun 26.

  PMID: 22893866 BACKGROUND

• Loustaud-Ratti VR, Cypierre A, Rousseau A, Yagoubi F, Abraham J, Fauchais AL, Carrier P, Lefebvre A, Bordessoule D, Vidal E, Sautereau D, Jaccard A. Non-invasive detection of hepatic amyloidosis: FibroScan, a new tool. Amyloid. 2011 Mar;18(1):19-24. doi: 10.3109/13506129.2010.543443. Epub 2011 Jan 10.

  PMID: 21219116 BACKGROUND

• Remacha A, Sanz C, Contreras E, De Heredia CD, Grifols JR, Lozano M, Nunez GM, Salinas R, Corral M, Villegas A; Spanish Society of Blood Transfusion; Spanish Society of Haematology and Haemotherapy. Guidelines on haemovigilance of post-transfusional iron overload. Blood Transfus. 2013 Jan;11(1):128-39. doi: 10.2450/2012.0114-11. Epub 2012 Jul 4. No abstract available.

  PMID: 22790272 BACKGROUND

• Gandon Y, Olivie D, Guyader D, Aube C, Oberti F, Sebille V, Deugnier Y. Non-invasive assessment of hepatic iron stores by MRI. Lancet. 2004 Jan 31;363(9406):357-62. doi: 10.1016/S0140-6736(04)15436-6.

  PMID: 15070565 BACKGROUND

• Hou P, Popat UR, Lindsay RJ, Jackson EF, Choi H. A practical approach for a wide range of liver iron quantitation using a magnetic resonance imaging technique. Radiol Res Pract. 2012;2012:207391. doi: 10.1155/2012/207391. Epub 2012 Dec 11.

  PMID: 23365743 BACKGROUND

• Argyropoulou MI, Astrakas L. MRI evaluation of tissue iron burden in patients with beta-thalassaemia major. Pediatr Radiol. 2007 Dec;37(12):1191-200; quiz 1308-9. doi: 10.1007/s00247-007-0567-1. Epub 2007 Aug 21.

  PMID: 17710390 BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hatoon Ezzat, MD

  Department of Medicine, Division of Hematology St. Paul's Hospital, University of British Columbia

  PRINCIPAL INVESTIGATOR

• Hinhin Ko, MD

  Department of Medicine, Division of Gastroenterology, St. Paul's Hospital, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

CA (1)