NCT01516853

Brief Summary

The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic, specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis, quantitative staging and treatment monitoring or hepatic iron overload.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration 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

First Submitted

Initial submission to the registry

August 17, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

3.4 years

First QC Date

August 17, 2011

Last Update Submit

December 4, 2019

Conditions

Iron OverloadHemosiderosis

Outcome Measures

Primary Outcomes (3)

  • Calibration Curve of Liver R2* vs. HIC Measured by FerriScan

    Accuracy of non-contrast R2\*-MRI for measuring hepatic iron concentration.

    Up to 1 day

  • Correlation of Ferritin and Liver R2*

    Linear correlation between serum ferritin values and MRI R2\* values

    up to 1 day

  • Correlation of Ferritin and HIC Measured by FerriScan

    Linear correlation between serum ferritin values and FerriScan hepatic iron measurement.

    up to 1 day

Secondary Outcomes (1)

  • Variability of cardiac R2* with different imaging parameters

    up to 1 day

Study Arms (2)

Patient Group

Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast MRI scan.

Device: Non-contrast MRI

Control Group

Subjects with no known history of iron overload or liver disease will undergo a serum iron measurement and a non-contrast MRI scan.

Device: Non-contrast MRI

Interventions

Non-contrast MRIDEVICE

Non-contrast MRI will be performed on each subject, at both 1.5T and 3.0T. Different MRI sequences (spin-echo and gradient-echo) will be used, with varying acquisition parameters (e.g., echo times, spatial resolution).

Control GroupPatient Group

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with known or suspected iron overload are identified and recruited in 3 different ways, 1) referral from the Division of Hematology/Oncology and Pediatric Hematology/Oncology, 2) via clinical reading of abdominal MRIs for evidence of iron overload, and 3) participants identified to have serum ferritin levels \>500 by UW Hospital Clinical Laboratory will be invited to participant. Controls were recruited from a recruitment database.

You may qualify if:

  • Controls: 18 years or older with no known history of iron overload or liver disease.
  • Patients: 10 years or older with known or suspected iron overload

You may not qualify if:

  • Patients with contraindications to MRI (eg. pacemaker, contraindicated metallic implants, claustrophobia, etc) and pregnant females (as determined by self-report during MRI safety screening) will be excluded.
  • For control subjects, those with known liver disease will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wisconsin Institutes for Medical Research

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

  • Hernando D, Cook RJ, Diamond C, Reeder SB. Magnetic susceptibility as a B0 field strength independent MRI biomarker of liver iron overload. Magn Reson Med. 2013 Sep;70(3):648-56. doi: 10.1002/mrm.24848. Epub 2013 Jun 25.

    PMID: 23801540RESULT

  • Sharma SD, Hernando D, Horng DE, Reeder SB. Quantitative susceptibility mapping in the abdomen as an imaging biomarker of hepatic iron overload. Magn Reson Med. 2015 Sep;74(3):673-83. doi: 10.1002/mrm.25448. Epub 2014 Sep 8.

    PMID: 25199788RESULT

  • Horng DE, Hernando D, Reeder SB. Quantification of liver fat in the presence of iron overload. J Magn Reson Imaging. 2017 Feb;45(2):428-439. doi: 10.1002/jmri.25382. Epub 2016 Jul 13.

    PMID: 27405703RESULT

MeSH Terms

Conditions

Iron OverloadHemosiderosis

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Scott B Reeder, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations

US(1)