Fully Automated High-Throughput Quantitative MRI of the Liver (NCT05294471) | Clinical Trial Compass
RecruitingNot Applicable
Fully Automated High-Throughput Quantitative MRI of the Liver
United States200 participantsStarted 2023-10-16
Plain-language summary
The purpose of this research is to see if a new automated magnetic resonance imaging (MRI) method will be able to improve the images taken of the liver. Participants will have either known or suspected liver disease, known or suspected iron overload syndrome, or be a healthy adult. Participants will be in the research study for one day.
Who can participate
Age range7 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria for Substudies 1, 2, 4, 5
Inclusion Criteria:
* Age 18 years or older
Exclusion Criteria:
* Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
* Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
Eligibility Criteria for Substudy 3
Inclusion Criteria:
* Age 7 years or older
* One of:
* Known or suspected liver iron overload
* Known or suspected elevated liver fat
Exclusion Criteria:
* Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
* 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
* Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
Eligibility Criteria for Substudy 6
Inclusion Criteria:
* Age 7 years or older
* Scheduled for a clinical abdominal MRI exam
Exclusion Criteria:
* Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
* Sedation required for MRI
* Pregnant or trying to become pregnant (as…
What they're measuring
1
Confirm the accuracy (ie: bias) of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload