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MRI ScansNCT04171635

Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy

An observational study of MRI Scans, run by Weill Medical College of Cornell University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for
MRI Scans
What is being tested?
Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI) and R2* Magnetic Resonance Imaging (MRI)
Type of treatment
Surgery or procedure
How many people
55 participants
Where
2 sitesUnited States
Study dates
16 Dec 2019to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Healthy subjects will be selected from the community through personal contact and written description of the research, and online advertising. Subjects will be selected at Columbia from those awaiting liver transplant to be enrolled in the study.

Who may be able to join

  • 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
Show all 9Show fewer
  • Able and willing to give consent
  • No known hematological and liver disease
  • No contraindications for MRI

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

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

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*.

Read the detailed description

The overall objective of this research is to improve the safety of iron-chelating therapy (ICT) in patients with transfusional iron overload by developing an accurate non-invasive measurement of the liver iron concentration (LIC), the best measure of the body iron burden in all forms of systemic iron overload. The scientific premise is that quantitative susceptibility mapping (QSM) provides a quantitative biophysical connection to LIC. Safe ICT requires careful adjustment of the iron chelator dose to the body iron burden to optimize iron excretion while avoiding chelator toxicity, including gastrointestinal disorders, audiovisual impairment, neutropenia, arthropathy, growth retardation, and hepatic and renal failure. QSM enables accurate measurement of LIC by overcoming the inherent cellular interference in current R2 (=1/T2) and R2* (=R2+R2') estimates that lack a well-defined biophysical connection to the LIC. A fundamental biophysical limitation of the R2 and R2* approaches is that intravoxel contents other than iron, including fibrosis, steatosis and necroinflammation, also alter relaxation. In the liver, paramagnetic iron stored in ferritin and hemosiderin is the dominant susceptibility source for QSM. Consequently, magnetic susceptibility measured by QSM has a simple linear relationship with the concentration of iron in the liver and is little affected by fibrosis, steatosis and necroinflammation. The investigator's research plan has 3 specific aims:

Aim 1. Develop hQSM for accurate measurement of LIC without interfering errors. Investigators will optimize data acquisition and processing for free-breathing navigator acquisition with robust fat-water separation.

Aim 2. Validate hQSM using histology and chemical measurement of LIC in liver explants. Investigators will assess the accuracies of LICs measured by hQSM and R2* in patients before liver transplant with histologic examination using the reference standard of chemical measurement of LIC in liver explants.

Aim 3. Evaluate hQSM in patients with transfusional iron overload under ICT. In patients regularly transfused for thalassemia major, investigators will conduct a double-blind clinical study comparing the accuracy of hQSM and R2* in measuring annual changes in LIC, using regression against the year-long amount of iron administered in red blood cell transfusions and the year-long cumulative dose of iron chelator.

Conditions
MRI Scans
Being tested
Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI), R2* Magnetic Resonance Imaging (MRI)
Keywords
Quantitative Susceptibility Mapping, Iron chelating therapy, Iron overload, Liver iron concentration, erythrocyte transfusion, liver transplantation, magnetic resonance imaging, thalassemia major
Medical subject headings
Iron Overload, beta-Thalassemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • R2* Magnetic Resonance Imaging (MRI)Radiation

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

Study groups in NCT04171635
Study groupRoleWhat they receive
Patients with transfusional iron overloadThe subject population of patients with transfusional iron overload awaiting liver transplant has been chosen because of the clinical indication for MRI examination every three months and the availability of liver explants for analysis after transplant. Explants will receive QSM or R2* MRI to provide a quantitative biophysical connection to liver iron concentration (LIC).
Receives: Radiation: Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI); Radiation: R2* Magnetic Resonance Imaging (MRI)
Healthy subjectsHealthy control subjects over the age of 21 with no known hematological or liver disease and no contraindications for MRI
Receives: Radiation: Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI); Radiation: R2* Magnetic Resonance Imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demonstration of efficacy of quantitative susceptibility mapping (QSM) MRI in quantifying liver iron concentration (LIC)

    Investigators will assess the accuracy of liver iron concentrations measured by QSM in patients before liver transplant with histologic examination using the gold standard chemical measurement of LIC in liver explants.

    Measured: Five years

Secondary outcomes (12)
  1. Fibrosis as determined by in vivo R2*, an MRI method that provides quantitative information on iron levels

    R2* is an imaging method used in MRI. R2* = (1/T2*) where R2* is a relaxation rate measured in units of Hz ([1/sec]). R2* is commonly used to look at iron levels by measuring the relaxation times of hydrogen nuclei affected by iron. The presence of the iron results in the shortening of proton relaxation times (T2*), thus increasing R2*.

    Measured: Five years

  2. Fibrosis as determined by in vitro R2*, an MRI method that provides quantitative information on iron levels

    R2* is an imaging method used in MRI. R2* = (1/T2*) where R2* is a relaxation rate measured in units of Hz ([1/sec]). R2* is commonly used to look at iron levels by measuring the relaxation times of hydrogen nuclei affected by iron. The presence of the iron results in the shortening of proton relaxation times (T2*), thus increasing R2*.

    Measured: Five years

  3. Fibrosis as determined by in vivo hQSM, an MRI post-processing technique that provides quantitative information on iron levels

    Quantitative susceptibility mapping (QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

    Measured: Five years

  4. Fibrosis as determined by in vitro hQSM, an MRI post processing technique that provides quantitative information on iron levels

    Quantitative susceptibility mapping (QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

    Measured: Five years

  5. Steatosis as determined by in vivo R2*, an MRI method that provides quantitative information on iron levels

    R2* is an imaging method used in MRI. R2* = (1/T2*) where R2* is a relaxation rate measured in units of Hz ([1/sec]). R2* is commonly used to look at iron levels by measuring the relaxation times of hydrogen nuclei affected by iron. The presence of the iron results in the shortening of proton relaxation times (T2*), thus increasing R2*.

    Measured: Five years

  6. Steatosis as determined by in vitro R2*, an MRI method that provides quantitative information on iron levels

    R2* is an imaging method used in MRI. R2* = (1/T2*) where R2* is a relaxation rate measured in units of Hz ([1/sec]). R2* is commonly used to look at iron levels by measuring the relaxation times of hydrogen nuclei affected by iron. The presence of the iron results in the shortening of proton relaxation times (T2*), thus increasing R2*.

    Measured: Five years

  7. Steatosis as determined by in vivo hQSM, an MRI post-processing technique that provides quantitative information on iron levels

    Quantitative susceptibility mapping (QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

    Measured: Five years

  8. Steatosis as determined by in vitro hQSM, an MRI post-processing technique that provides quantitative information on iron levels

    Quantitative susceptibility mapping (QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

    Measured: Five years

  9. Necroinflammation as determined by in vivo R2*, an MRI method that provides quantitative information on iron levels

    R2* is an imaging method used in MRI. R2* = (1/T2*) where R2* is a relaxation rate measured in units of Hz ([1/sec]). R2* is commonly used to look at iron levels by measuring the relaxation times of hydrogen nuclei affected by iron. The presence of the iron results in the shortening of proton relaxation times (T2*), thus increasing R2*.

    Measured: Five years

  10. Necroinflammation as determined by in vitro R2*, an MRI method that provides quantitative information on iron levels

    R2* is an imaging method used in MRI. R2* = (1/T2*) where R2* is a relaxation rate measured in units of Hz ([1/sec]). R2* is commonly used to look at iron levels by measuring the relaxation times of hydrogen nuclei affected by iron. The presence of the iron results in the shortening of proton relaxation times (T2*), thus increasing R2*.

    Measured: Five years

  11. Necroinflammation as determined by in vivo hQSM, an MRI post-processing technique that provides quantitative information on iron levels

    Quantitative susceptibility mapping (QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

    Measured: Five years

  12. Necroinflammation as determined by in vitro hQSM, an MRI post-processing technique that provides quantitative information on iron levels

    Quantitative susceptibility mapping (QSM) is widely used by the imaging research community in applications to detect iron. Tissue can become magnetized in response to a magnetic field, and the extent of magnetization is known as susceptibility, which arises from unpaired electrons in iron or external sources such as contrast agents. QSM permits visualization of the sizes and shapes of iron sources, delivers precise estimates of iron concentrations (units: parts per billion [ppb] or parts per million [ppm]).

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start16 Dec 2019
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04171635
Sponsor's protocol ID
1706018263
Other IDs
R01DK116126-01A1
Status last verified
Feb 2026
First submitted
7 Nov 2019
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of MRI Scans, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstration of efficacy of quantitative susceptibility mapping (QSM) MRI in quantifying liver iron concentration (LIC) (time frame: Five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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