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NCT00587535 Clinical Trial

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

Hemochromatosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00587535
Other study ID # 1478-03
Secondary ID
Status Completed
Phase N/A
First received December 21, 2007
Last updated January 20, 2016
Start date August 2003
Est. completion date July 2011

Study information
Verified date January 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Undergoing liver biopsy for suspected or known hemochromatosis

- Undergoing liver biopsy for living-related liver donation evaluation

Exclusion Criteria:

- Contraindication to MRI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of MR in quantifying liver iron one time point No
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