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

NCT ID: NCT00587535

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemochromatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemochromatosis

Hemochromatosis

No interventions assigned to this group

Living-related liver donation

Living-related liver donation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Contraindication to MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeff Fidler

Professor of Radiology College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeff L Fidler, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1478-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Kidney Fibrosis and MRI
NCT03964948 COMPLETED NA
Imaging Techniques in MRI
NCT01130545 RECRUITING