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
  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:


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 August 25, 2016