Using MRI to improve iron measurement for patients needing iron chelation therapy
Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy in Transfusional Iron Overload
This study is testing a new MRI technique to see if it can safely measure iron levels in the liver of patients with iron overload, so they can avoid invasive procedures like liver biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04171635 on ClinicalTrials.gov |
What this trial studies
This research aims to develop a new MRI method called Quantitative Susceptibility Mapping (QSM) to accurately measure liver iron concentrations in patients with iron overload, eliminating the need for invasive liver biopsies. The study will compare QSM measurements with traditional MRI methods (R2 and R2*) and chemical analysis of liver samples from patients undergoing liver transplants. By providing a more reliable assessment of liver iron, the study seeks to enhance the safety and effectiveness of iron-chelating therapy in managing iron overload conditions.
Who should consider this trial
Good fit: Ideal candidates include patients with thalassemia major receiving deferasirox as their sole iron chelating therapy and healthy individuals aged 21 and older.
Not a fit: Patients with a history of auditory or ocular toxicity related to iron chelation therapy or those unable to tolerate MRI examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective iron-chelating therapies for patients with iron overload.
How similar studies have performed: Other studies have shown promise in using advanced MRI techniques for measuring iron levels, but the specific application of QSM in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
New York, New York and 1 other locations
- Weill Cornell Medical College — New York, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Gary M Brittenham, MD — Columbia University
- Study coordinator: Gary M Brittenham, MD
- Email: gmb31@cumc.columbia.edu
- Phone: 212-305-7005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.