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Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration

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ClinicalTrials.gov Identifier: NCT00587535
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jeff Fidler, Mayo Clinic

Study Description
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Brief Summary:
The purpose of this study is to determine if a new MR pulse sequence is accurate in determining how much iron is in the liver.

Condition or disease
Hemochromatosis

Detailed Description:
Quantification of liver iron requires liver biopsy and histological assessment. New rapid MR techniques allow determination of liver relaxation times that can be altered with increasing iron deposition. The purpose of this study is to compare the results obtained with MRI to liver biopsy and iron quantification in patients undergoing liver biopsy in the setting of hemochromatosis.

Study Design
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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration
Study Start Date : August 2003
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemochromatosis Iron

Groups and Cohorts
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Group/Cohort
Hemochromatosis
Hemochromatosis
Living-related liver donation
Living-related liver donation


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of MR in quantifying liver iron [ Time Frame: one time point ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Gastroenterology Clinic; Liver Transplant Center; Surgery Clinic
Criteria

Inclusion Criteria:

  • Undergoing liver biopsy for suspected or known hemochromatosis
  • Undergoing liver biopsy for living-related liver donation evaluation

Exclusion Criteria:

  • Contraindication to MRI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587535


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeff L Fidler, MD Mayo Clinic
More Information
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Responsible Party: Jeff Fidler, Professor of Radiology College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587535     History of Changes
Other Study ID Numbers: 1478-03
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeff Fidler, Mayo Clinic:
hemochromatosis
liver cirrhosis
liver diseases

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
 Iron Metabolism Disorders
Metabolic Diseases
Liver Extracts
Hematinics