MRI QSM Imaging for Iron Overload

Iron Overload Clinical Trial

Official title:

MRI-based Quantitative Susceptibility Mapping of Hepatic Iron Overload

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631718
• Other study ID #: 2020-0761
• Secondary ID: 1R01DK117354-01A
• Status: Completed
• Start date: January 18, 2022
• Est. completion date: April 29, 2024

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall goal of this project is to develop and validate a novel technique for Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM) of the abdomen, for non-invasive assessment of liver iron deposition. In this work, study team will develop and optimize advanced data acquisition and image reconstruction methods to enable QSM of the abdomen. Further, investigators will determine the accuracy, repeatability, and reproducibility of abdominal QSM for iron quantification in patients with liver iron overload.

Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Accurate assessment of liver iron concentration is critical for the detection and staging of iron overload as well as for longitudinal monitoring during treatment.

In summary, this project will develop a novel MRI-based QSM technique designed for the abdomen and will validate it in pediatric and adult patients with liver iron overload. Upon successful validation, QSM will provide accurate, repeatable, and reproducible quantification of LIC based on a fundamental property of tissue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 29, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Ages 10 years or older at University of Wisconsin - Madison

• Age 5 years or older at Stanford

• Known or suspected iron overload

Exclusion Criteria:

• Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, etc)

• Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)

• Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:

• The subject has their own prescription for the medication.

• The informed consent process is conducted prior to the self-administration of this medication

• They come to the research visit with a driver

Related Conditions & MeSH terms

• Hemochromatosis
• Hemosiderosis
• Iron Overload

Intervention

Radiation:
• Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)
MRI-based QSM methods estimate the susceptibility of tissues based on measuring the magnetic field distortion produced by the tissues themselves. Upon successful validation, MRI-based abdominal QSM will provide accurate, repeatable, and reproducible quantification of Liver iron concentration (LIC) that is independent of the distribution of iron and does not require calibration.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin
United States	School of Medicine, Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishing the accuracy of MRI-QSM of the liver using SQUID-BLS as a reference	Determine the accuracy of abdominal QSM to quantify liver iron concentration at 1.5T and 3T, in pediatric and adult patients with liver iron overload, using superconducting quantum interference device (SQUID)-based biomagnetic liver susceptometry (BLS) as the reference.	1.5 hours
Primary	Establishing the repeatability of MRI-QSM of the liver	Repeatability of MRI-QSM of the liver will be established in both pediatrics and adult participants. Each participant will be scanned at both 1.5T and 3T and at UW will repeat one of the field strengths to assess repeatability. Therefore, each participant at UW will undergo 3 MRI exams and each participant at Stanford 2 MRI exams.; Repeatability will not be tested at Stanford in order to avoid exhaustion of the patients (many of whom will be children), and to ensure the completion of acquisitions at both field strengths for validation of accuracy versus SQUID-BLS. Scanning will take 1.5 hour at University of Wisconsin and I hour at Stanford	up to 1.5 hours
Primary	Establishing the reproducibility of MRI-QSM of the liver	The reproducibility of abdominal MRI-based Quantitative Susceptibility Mapping (MRI-QSM) will be characterized across field strengths (1.5Tesla and 3Tesla), in both pediatric and adult participants with iron overload The repeated acquisitions at 1.5T and 3T will enable analysis of reproducibility of MRI-QSM across field strengths. At UW only, participants repeat either the 1.5T or 3T exam, with consideration given to the subject's schedule and magnet availability. Repeat tests will be performed after removing the participants from the magnet and repositioning with new localizer images. Repeatability will not be tested at Stanford in order to avoid exhaustion of the patients (many of whom will be children), and to ensure the completion of acquisitions at both field strengths for validation of accuracy versus SQUID-BLS.; Scanning will take 1.5 hour at University of Wisconsin and I hour at Stanford	up to 1.5 hours
Primary	Optimizing MRI-based QSM performance by using multiple QSM reconstruction and measurement	Multiple QSM reconstructions will be applied to each acquired dataset, to evaluate the effect of each reconstruction component on the performance of QSM.; Susceptibility measurements will be made by placing a region-of-interest in each of the nine Couinaud segments of the liver. This will allow segment-by-segment analysis as well as whole-liver analysis (by averaging over the 9 segments) of the performance of QSM. The reader performing MRI analysis will be blinded to SQUID results.; Scanning will take 1.5 hour at University of Wisconsin and I hour at Stanford.	up to 1.5 hours
Primary	MRI-QSM data acquisition with Breath held	An optimized acquisition will obtain 3D whole liver coverage within a ~20 second breath-hold. Data will be collected at 1.5T and 3T	1.5 hours
Primary	MRI-QSM data acquisition with Free Breathing	The optimized free-breathing acquisitions (using bellows, butterfly navigators, and 2D sequential acquisitions and requiring 3-5 min each) will be performed. Data will be collected at 1.5T and 3T	1.5 hours
Secondary	Comparison of MRI-based QSM of the liver to serum ferritin measurements	MRI-based QSM of the liver will be compared to serum ferritin measurements to validate MRI-QSM method. MRI-QSM visit will be scheduled within +/-2 days of serum ferritin measurement visit	up to 3.5 hours