Clinical trial NCT04631718: MRI QSM Imaging for Iron Overload
Official title: MRI-based Quantitative Susceptibility Mapping of Hepatic Iron Overload
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemochromatosis
Iron Overload
Keywords: Liver iron concentration
Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Stanford University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-11-17
Enrollment: 63
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected iron overload will be identified and recruited from the UWHC Hematology Adult and Pediatric clinics or Stanford Hospital and Clinics. Briefly, patients will be identified and recruited in collaboration with patient providers (either by introduction during a clinical visit or by a referral from a physician), using flyers posted in relevant clinics, or from previous related studies where the patient consented to being contacted about future research opportunities.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Establishing the accuracy of MRI-QSM of the liver using SQUID-BLS as a reference
timeFrame: 1.5 hours
measure: Establishing the repeatability of MRI-QSM of the liver
timeFrame: up to 1.5 hours
measure: Establishing the reproducibility of MRI-QSM of the liver
timeFrame: up to 1.5 hours
measure: Optimizing MRI-based QSM performance by using multiple QSM reconstruction and measurement
timeFrame: up to 1.5 hours
measure: MRI-QSM data acquisition with Breath held
timeFrame: 1.5 hours
measure: MRI-QSM data acquisition with Free Breathing
timeFrame: 1.5 hours
Secondary outcomes:
measure: Comparison of MRI-based QSM of the liver to serum ferritin measurements
timeFrame: up to 3.5 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: School of Medicine, Stanford University
state: California
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Diego Hernando, PhD
role: PRINCIPAL_INVESTIGATOR
References: