We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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

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

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 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
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemochromatosis Iron
U.S. FDA Resources

Living-related liver donation
Living-related liver donation

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to MRI

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

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Jeff L Fidler, MD Mayo Clinic

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:
liver cirrhosis
liver diseases

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