Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy

NCT04171635 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-02-27

No results posted yet for this study

Summary

The overall goal of this research is to help develop a new magnetic resonance (MR) method, Quantitative Susceptibility Mapping (QSM), to improve the measurement of liver iron concentrations without the need for a liver biopsy. Measurement of liver iron is important to diagnose and treat patients who have too much iron in their bodies (iron overload). Liver iron measurements by current MRI methods (R2 and R2\*) can be inaccurate because of the effects of fat, fibrosis and other abnormalities. QSM should not be affected by these factors and should be free of these errors. In this study, MRI measurements (QSM, R2 and R2\*) of iron in patients before liver transplant will be compared with chemical analysis of iron in liver explants (livers removed from patients undergoing liver transplant). The liver explants would otherwise be discarded. Investigators expect that this study will show that the new MRI method, QSM, is superior to the current MRI methods, R2 and R2\*.

Conditions

  • MRI Scans

Interventions

RADIATION

Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI)

Investigators will validate hepatic QSM (hQSM) using histological examination and chemical measurement of liver iron concentration (LIC). Patients will undergo clinical MRI in Aim 1. In patients with increased LIC their liver explants will undergo MRI, pathological examination, and chemical determination of the LIC.

RADIATION

R2* Magnetic Resonance Imaging (MRI)

Investigators will be able to validate hQSM in measuring liver iron concentration (LIC) by comparing it to this traditional MRI technique

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER
  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Gary M Brittenham, MD · Columbia University

  • Yi Wang, PhD · Weill Medical College of Cornell University

  • Sujit S Sheth, MD · Weill Medical College of Cornell University

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171635 on ClinicalTrials.gov