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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jeff Fidler, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00587535

First received: December 21, 2007

Last updated: January 20, 2016

Last verified: January 2016

History of Changes

Purpose

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
Hemochromatosis


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary hemochromatosis

MedlinePlus related topics: Hemochromatosis Iron

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Accuracy of MR in quantifying liver iron [ Time Frame: one time point ] [ Designated as safety issue: No ]


Enrollment:	18
Study Start Date:	August 2003
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Hemochromatosis Hemochromatosis
Living-related liver donation Living-related liver donation

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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
Study First Received:	December 21, 2007
Last Updated:	January 20, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016

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