Optimizing Liver MRI Using Breath-Holding With and Without Oxygen
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, San Francisco
About this trial
The goal of this interventional study (clinical trial) is to learn if different breath-holding techniques, with and without extra oxygen, can improve the quality of abdominal Magnetic Resonance Imaging (MRI) images in healthy adults, ages 18-75.
The main questions it aims to answer are:
* Does breath-holding at end-expiration improve image quality in abdominal MRI scans? * Does adding oxygen while breath-holding further reduce motion artifacts in abdominal MRI scans?
Researchers will compare breath-holding with and without oxygen to see if using oxygen improves image quality during MRI scans.
Participants will:
* Be pre-screened for MRI safety and trained on breath-hold procedures * Have one non-contrast abdominal MRI scan at the University of California San Francisco (UCSF) China Basin Imaging Center * Use two different breath-holding techniques during the scan, with and without oxygen * Complete one study visit lasting about 45 minutes to 1 hour
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject must be within 18-75 years of age;
Subject must be able to hear and understand instructions without assistive devices;
Subject must provide written informed consent;
Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements;
Disqualifiers
Subjects with a weight greater than 499 lbs;
Subjects that have metallic/conductive or electrically/magnetically active implants without Magnetic Resonance (MR) Safe or Magnetic Resonance (MR) Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator;
Subjects that have implants with MR Unsafe labeling;
Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR environment or scan protocol;
Trial design
Design model
Crossover
Treatments tested in this trial
Breath-hold conditions
Other interventionFunctional Residual Capacity/End-Expiration (breath-hold technique) with/without oxygen to optimize MRI image quality.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Functional Residual Capacity/End-Expiration Without OxygenExperimental treatment 1 intervention
Group B: Functional Residual Capacity/End-Expiration With OxygenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Liver MRI Image Quality (Motion Artifacts)
Image quality of liver MRI scans will be assessed by quantifying the degree of respiratory motion artifacts under two breath-holding conditions: Functional Residual Capacity (FRC) alone and FRC with oxygen supplementation. Reduced artifacts indicate improved image clarity and feasibility of the technique. Unit of Measure: Motion artifact score (ordinal scale, e.g., 1-5).
Time frame
During the single MRI session (approximately 1 hour)Secondary outcomes
1
Breath-Holding Duration
The duration (in seconds) that participants can comfortably sustain a breath-hold under each condition (FRC alone and FRC with oxygen supplementation). Unit of Measure: Seconds.
Time frame
During the MRI session (approximately 1 hour)2
Oxygen Saturation During Breath-Holding
Peripheral oxygen saturation will be monitored during each breath-hold condition to assess physiologic tolerance and safety. Unit of Measure: Percent oxygen saturation (%).
Time frame
During the MRI session (approximately 1 hour)3
Adverse Events and Participant-Reported Discomfort
Number and type of adverse events, as well as participant-reported discomfort, occurring during or immediately after each breath-hold condition. Unit of Measure: Number of events.
Time frame
During and immediately after the MRI session (up to 1 hour)Sponsors and contacts
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Source ClinicalTrials.gov