University of California, San Francisco
San Francisco, California, 94143, United States
Location status: Recruiting
NCT Number: NCT07135401
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Location status: Recruiting
This is a within-subject, randomized crossover interventional study conducted at UCSF China Basin Imaging Center using a 3 Tesla Magnetic Resonance Imaging (3T MRI scanner). The study aims to optimize abdominal MRI protocols by evaluating the impact of breath-holding techniques, with and without oxygen supplementation, on motion artifacts and overall image quality.
Each participant will undergo non-contrast abdominal MRI scans using two breath-hold conditions: (1) Functional Residual Capacity (FRC)/end-expiration without oxygen and (2) FRC/end-expiration with preoxygenation. The order of these conditions will be randomized to control for potential order effects, and each participant will serve as their own control to reduce inter-individual variability.
T2-weighted and Magnetic Resonance Cholangiopancreatography (MRCP) sequences will be acquired during each breath-hold trial. MRI-compatible pulse oximetry will be used to monitor oxygen saturation and pulse rate throughout scanning. A radiology research nurse will be present if additional monitoring is needed based on the participant's pre-screening or intra-scan findings. Participants will receive training on breath-hold procedures prior to imaging to improve consistency and comfort during scanning.
Two board-certified radiologists, blinded to the breath-hold condition, will independently assess each image set for motion artifacts and overall image quality using a standardized 5-point grading system. The grading will range from very poor (1) to very good (5) based on sharpness, visibility of anatomical details, and presence of blurring or signal loss.
Inter-rater reliability will be evaluated using the Intraclass Correlation Coefficient (ICC). Statistical analyses will include repeated measures ANOVA to compare image quality scores across breath-holding conditions. Descriptive analyses will assess breath-hold durations and participant characteristics (e.g., age, gender) in relation to image quality and safety outcomes, including oxygen saturation and self-reported comfort.
This study involves minimal risk, does not utilize contrast agents, and is intended to support the development of motion-reduced, efficient liver MRI protocols, particularly for living liver donor evaluation. Data collected during the study will not be used for clinical decision-making.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Functional Residual Capacity/End-Expiration (breath-hold technique) with/without oxygen to optimize MRI image quality.
Time frame: During the single MRI session (approximately 1 hour)
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 MRI session (approximately 1 hour)
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)
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 and immediately after the MRI session (up to 1 hour)
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.
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Optimizing MRI Liver Imaging: Evaluating Breath-Holding Techniques and Oxygen Supplementation to Reduce Respiratory Motion Artifacts
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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