RECRUITING

Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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\*.

Official Title

Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy in Transfusional Iron Overload

Quick Facts

Study Start:2019-12-16
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04171635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Established diagnosis of thalassemia major
  2. * Treatment with deferasirox formulated as Jadenu® as the sole iron chelating therapy (ICT)
  3. * Regular transfusion with records maintained in the Cornell Thalassemia Program
  4. * 2 years of age or older
  5. * Females who are not pregnant
  6. * Men and women aged 21 years or older
  7. * Able and willing to give consent
  8. * No known hematological and liver disease
  9. * No contraindications for MRI
  1. * A history of auditory or ocular toxicity related to ICT
  2. * A history of poor adherence to prescribed therapy
  3. * An inability to tolerate MRI examinations
  4. * Treatment for mental illness
  5. * Institutionalization or imprisonment

Contacts and Locations

Study Contact

Gary M Brittenham, MD
CONTACT
212-305-7005
gmb31@cumc.columbia.edu

Principal Investigator

Gary M Brittenham, MD
PRINCIPAL_INVESTIGATOR
Columbia University
Yi Wang, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Sujit S Sheth, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medical College
New York, New York, 10021
United States
Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Gary M Brittenham, MD, PRINCIPAL_INVESTIGATOR, Columbia University
  • Yi Wang, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
  • Sujit S Sheth, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-16
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2019-12-16
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Quantitative Susceptibility Mapping
  • Iron chelating therapy
  • Iron overload
  • Liver iron concentration
  • erythrocyte transfusion
  • liver transplantation
  • magnetic resonance imaging
  • thalassemia major

Additional Relevant MeSH Terms

  • MRI Scans