NCT04171635Completed
Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy
Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy in Transfusional Iron Overload
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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\*.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 55 (actual)
- First submitted
- 7 Nov 2019
- Start date
- 16 Dec 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Thalassaemia
- NCT number
- NCT04171635
What you commit to
- Study type: Observational
- Participants enrolled: 55
- From 16 Dec 2019 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of auditory or ocular toxicity related to ICT
- A history of poor adherence to prescribed therapy
- Treatment for mental illness
Other
- An inability to tolerate MRI examinations
- Institutionalization or imprisonment
Who the study is looking for
- 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
- Men and women aged 21 years or older
- Able and willing to give consent
- No known hematological and liver disease
- No contraindications for MRI
Age in the registry: 2 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.