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RecruitingNCT07135401

Optimizing Liver MRI Using Breath-Holding With and Without Oxygen

Optimizing MRI Liver Imaging: Evaluating Breath-Holding Techniques and Oxygen Supplementation to Reduce Respiratory Motion Artifacts

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERBreath-hold conditionsFunctional Residual Capacity/End-Expiration (breath-hold technique) with/without oxygen to optimize MRI image quality.

Timeline

Start date
2025-12-01
Primary completion
2026-06-01
Completion
2026-08-01
First posted
2025-08-22
Last updated
2026-04-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07135401. Inclusion in this directory is not an endorsement.

Optimizing Liver MRI Using Breath-Holding With and Without Oxygen (NCT07135401) · Clinical Trials Directory