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NCT Number: NCT07135401

Optimizing Liver MRI Using Breath-Holding With and Without Oxygen

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Holland Stacey Stacey

CONTACT

[email protected]

415-420-5100

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Subject is able to remain still for duration of imaging procedure (approximately 30-45 minutes)

Exclusion criteria

  • 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;
  • Subjects who have a contraindication to MRI per the screening policy of the participating site;
  • Subjects with any respiratory or cardiovascular condition that could compromise safe breath holding;
  • Subjects who are female and pregnant

Treatment and study plan

Breath-hold conditions

Other

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

Primary outcomes

  1. Liver MRI Image Quality (Motion Artifacts)

    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).

Secondary outcomes

  1. Breath-Holding Duration

    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.

  2. Oxygen Saturation During Breath-Holding

    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 (%).

  3. Adverse Events and Participant-Reported Discomfort

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

John P Roberts, MD

CONTACT

[email protected]

415-353-3677

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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