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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00587535

First Posted: January 7, 2008

Last Update Posted: January 22, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Jeff Fidler, Mayo Clinic

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

Genetic and Rare Diseases Information Center resources: Hemochromatosis Type 3

U.S. FDA Resources

Further study details as provided by Jeff Fidler, Mayo Clinic:

Primary Outcome Measures:

Accuracy of MR in quantifying liver iron [ Time Frame: one time point ]


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


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 Submitted:	December 21, 2007
First Posted:	January 7, 2008
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

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