NCT07135401

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

August 6, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

August 6, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

abdominal MRIbreath-hold techniquefunctional residual capacityimage qualitynon-contrast MRIliver MRIend-expirationpreoxygenationoxygen supplementationradiologyrespiratory motion controlT2-weighted imagingliving liver donormotion artifact3T MRIUCSFmotion artifact reductionhyperventilationend-inspiration

Outcome Measures

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).

    During the single MRI session (approximately 1 hour)

Secondary Outcomes (3)

  • Breath-Holding Duration

    During the MRI session (approximately 1 hour)

  • Oxygen Saturation During Breath-Holding

    During the MRI session (approximately 1 hour)

  • Adverse Events and Participant-Reported Discomfort

    During and immediately after the MRI session (up to 1 hour)

Study Arms (2)

Functional Residual Capacity/End-Expiration Without Oxygen

EXPERIMENTAL

Participants will undergo abdominal MRI scans while performing breath-holding at end-expiration without oxygen supplementation. T2-weighted and MRCP sequences will be acquired during breath-hold trials.

Other: Breath-hold conditions

Functional Residual Capacity/End-Expiration With Oxygen

EXPERIMENTAL

Participants will undergo abdominal MRI scans while performing breath-holding at end-expiration with oxygen supplementation administered prior to. T2-weighted and MRCP sequences will be acquired during breath-hold trials.

Other: Breath-hold conditions

Interventions

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

Functional Residual Capacity/End-Expiration With OxygenFunctional Residual Capacity/End-Expiration Without Oxygen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (7)

  • Yoo JL, Lee CH, Park YS, Kim JW, Lee J, Kim KA, Seol HY, Park CM. The Short Breath-Hold Technique, Controlled Aliasing in Parallel Imaging Results in Higher Acceleration, Can Be the First Step to Overcoming a Degraded Hepatic Arterial Phase in Liver Magnetic Resonance Imaging: A Prospective Randomized Control Study. Invest Radiol. 2016 Jul;51(7):440-6. doi: 10.1097/RLI.0000000000000249.

    PMID: 26807896BACKGROUND
  • Vu KN, Haldipur AG, Roh AT, Lindholm P, Loening AM. Comparison of End-Expiration Versus End-Inspiration Breath-Holds With Respect to Respiratory Motion Artifacts on T1-Weighted Abdominal MRI. AJR Am J Roentgenol. 2019 May;212(5):1024-1029. doi: 10.2214/AJR.18.20239. Epub 2019 Mar 5.

    PMID: 30835515BACKGROUND
  • Towell V, Gysen KV, Cross S, Kk Low G. Efficacy of preoxygenation administration in volunteers, in extending the end-expiration breath-hold duration for application to abdominal radiotherapy. Tech Innov Patient Support Radiat Oncol. 2023 May 4;26:100208. doi: 10.1016/j.tipsro.2023.100208. eCollection 2023 Jun.

    PMID: 37207259BACKGROUND
  • Parkes MJ, Green S, Stevens AM, Parveen S, Stephens R, Clutton-Brock TH. Safely prolonging single breath-holds to >5 min in patients with cancer; feasibility and applications for radiotherapy. Br J Radiol. 2016 Jul;89(1063):20160194. doi: 10.1259/bjr.20160194.

    PMID: 27168468BACKGROUND
  • Khot R, McGettigan M, Patrie JT, Feuerlein S. Quantification of gas exchange-related upward motion of the liver during prolonged breathholding-potential reduction of motion artifacts in abdominal MRI. Br J Radiol. 2020 Feb 1;93(1106):20190549. doi: 10.1259/bjr.20190549. Epub 2019 Dec 10.

    PMID: 31778311BACKGROUND
  • Funk E, Anderzen-Carlsson A, Ingverud P, Leander A, Thunberg P. Patient-initiated breath-holds in MRI: an alternative for reducing respiratory artifacts and improving image quality. Clin Imaging. 2015 Jul-Aug;39(4):619-22. doi: 10.1016/j.clinimag.2014.12.007. Epub 2014 Dec 13.

    PMID: 25555833BACKGROUND
  • Chandarana H, Feng L, Ream J, Wang A, Babb JS, Block KT, Sodickson DK, Otazo R. Respiratory Motion-Resolved Compressed Sensing Reconstruction of Free-Breathing Radial Acquisition for Dynamic Liver Magnetic Resonance Imaging. Invest Radiol. 2015 Nov;50(11):749-56. doi: 10.1097/RLI.0000000000000179.

    PMID: 26146869BACKGROUND

MeSH Terms

Conditions

Hyperventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John P Roberts, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John P Roberts, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 22, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations