Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration
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| ClinicalTrials.gov Identifier: NCT00587535 |
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Recruitment Status
:
Completed
First Posted
: January 7, 2008
Last Update Posted
: January 22, 2016
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Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Jeff Fidler, Mayo Clinic
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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 |
|---|
| Hemochromatosis |
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 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Hereditary hemochromatosis
U.S. FDA Resources
| Group/Cohort |
|---|
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Hemochromatosis
Hemochromatosis
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Living-related liver donation
Living-related liver donation
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Primary Outcome Measures
:
- Accuracy of MR in quantifying liver iron [ Time Frame: one time point ]
Information from the National Library of Medicine
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| 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
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 |
| 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:
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hemochromatosis liver cirrhosis liver diseases |
Additional relevant MeSH terms:
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Hemochromatosis Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Iron Overload |
Iron Metabolism Disorders Metabolic Diseases Liver Extracts Hematinics |