NCT00587535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

7.9 years

First QC Date

December 21, 2007

Last Update Submit

January 20, 2016

Conditions

Hemochromatosis

Keywords

hemochromatosisliver cirrhosisliver diseases

Outcome Measures

Primary Outcomes (1)

  • Accuracy of MR in quantifying liver iron

    one time point

Study Arms (2)

Hemochromatosis

Hemochromatosis

Living-related liver donation

Living-related liver donation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gastroenterology Clinic; Liver Transplant Center; Surgery Clinic

You may qualify if:

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

You may not qualify if:

  • Contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

HemochromatosisLiver CirrhosisLiver Diseases

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeff L Fidler, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology College of Medicine

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

August 1, 2003

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 22, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)