Summary

Eligibility
for people ages 18-75 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by John P Roberts, MD

Description

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

Official Title

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

Details

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.

Keywords

MRI, MRI Image Enhancement, abdominal MRI, breath-hold technique, functional residual capacity, image quality, non-contrast MRI, liver MRI, end-expiration, preoxygenation, oxygen supplementation, radiology, respiratory motion control, T2-weighted imaging, living liver donor, motion artifact, 3T MRI, UCSF, motion artifact reduction, hyperventilation, end-inspiration, Breath-hold conditions

Eligibility

You can join if…

Open to people ages 18-75

  • 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)

You CAN'T join if...

  • 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

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07135401
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated