Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587535
First received: December 21, 2007
Last updated: July 20, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|
|
1
Hemochromatosis
|
|
2
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 |
| 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
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
No publications provided
| Responsible Party: | Jeff Fidler, MD -principal investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00587535 History of Changes |
| Other Study ID Numbers: | 1478-03 |
| Study First Received: | December 21, 2007 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
hemochromatosis liver cirrhosis liver diseases |
Additional relevant MeSH terms:
|
Hemochromatosis Genetic Diseases, Inborn Iron Metabolism Disorders Iron Overload |
Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors |
ClinicalTrials.gov processed this record on March 03, 2015