Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy

Completed

Conditions studied: MRI Scans

In brief

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\*.

Key facts

Study ID: NCT04171635
Run by: Weill Medical College of Cornell University
People needed: 55
Starts: 2019-12-16
Expected to finish: 2025-12-31
Last updated by the study team: 2026-02-27

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Established diagnosis of thalassemia major
Treatment with deferasirox formulated as Jadenu® as the sole iron chelating therapy (ICT)
Regular transfusion with records maintained in the Cornell Thalassemia Program
2 years of age or older
Females who are not pregnant
Inclusion Criteria (for healthy subjects):
Men and women aged 21 years or older
Able and willing to give consent
No known hematological and liver disease
No contraindications for MRI

You may not qualify if…

A history of auditory or ocular toxicity related to ICT
A history of poor adherence to prescribed therapy
An inability to tolerate MRI examinations
Treatment for mental illness
Institutionalization or imprisonment

Where it is running

Weill Cornell Medical College — New York, New York, United States
Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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