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NCT04171635 · ClinicalTrials.gov registry record
Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy
A clinical trial, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- 55
- Enrollment target
NCT04171635: Completed study, sponsored by Weill Medical College of Cornell University.
NCT04171635 is a clinical trial that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04171635 has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- 55 participants
- Enrollment target
Study 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. 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\*.
Primary Outcome
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.
Interventions
- RADIATION Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI)
- RADIATION R2* Magnetic Resonance Imaging (MRI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2025-12-31 |
What the finished NCT04171635 record still lists
NCT04171635 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI) is the first listed.
NCT04171635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04171635 about?
NCT04171635 is a clinical study titled "Quantitative Susceptibility Mapping (QSM) to Guide Iron Chelating Therapy". 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...
What is the current status of trial NCT04171635?
This trial is currently completed. The enrollment target is 55 participants. The study started on 2019-12-16. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT04171635?
The interventions under investigation include: Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI) (RADIATION), R2* Magnetic Resonance Imaging (MRI) (RADIATION).
Who is sponsoring clinical trial NCT04171635?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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