MRINCT07135401
Optimizing Liver MRI Using Breath-Holding With and Without Oxygen
A study testing Breath-hold conditions in people with MRI and MRI Image Enhancement, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- MRI, MRI Image Enhancement
- What is being tested?
- Breath-hold conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Holland Stacey Stacey, 415-420-5100, holland.stacey@ucsf.edu
About this study
Official title: Optimizing MRI Liver Imaging: Evaluating Breath-Holding Techniques and Oxygen Supplementation to Reduce Respiratory Motion Artifacts
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:
Read more
- 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
Read the 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
- MRI, MRI Image Enhancement
- Being tested
- Breath-hold conditions
- Keywords
- 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
- Medical subject headings
- Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-hold conditionsOther
Functional Residual Capacity/End-Expiration (breath-hold technique) with/without oxygen to optimize MRI image quality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Breath-hold conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the single MRI session (approximately 1 hour)
Secondary outcomes (3)
Breath-Holding Duration
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.
Measured: During the MRI session (approximately 1 hour)
Oxygen Saturation During Breath-Holding
Peripheral oxygen saturation will be monitored during each breath-hold condition to assess physiologic tolerance and safety. Unit of Measure: Percent oxygen saturation (%).
Measured: During the MRI session (approximately 1 hour)
Adverse Events and Participant-Reported Discomfort
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.
Measured: During and immediately after the MRI session (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MRIStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Roberts, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135401
- Sponsor's protocol ID
- 25-44459
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26807896Vu 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.
PubMed 30835515Towell 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.
PubMed 37207259Parkes 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.
PubMed 27168468Khot 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.
PubMed 31778311Funk 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.
PubMed 25555833Chandarana 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.
PubMed 26146869
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing MRI Liver Imaging: Evaluating Breath-Holding Techniques and Oxygen Supplementation to Reduce Respiratory Motion Artifacts
- ClinicalTrials.gov ID
- NCT07135401
- Acronym / sponsor ID
- 25-44459
- Conditions
- MRI, MRI Image Enhancement
- Keywords
- abdominal MRI, breath-hold technique, functional residual capacity, image quality, non-contrast MRI, liver MRI, end-expiration, preoxygenation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Residual Capacity/End-Expiration Without Oxygen | Experimental | Other: Breath-hold conditionsParticipants 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. |
| Functional Residual Capacity/End-Expiration With Oxygen | Experimental | Other: Breath-hold conditionsParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath-hold conditionsFunctional Residual Capacity/End-Expiration (breath-hold technique) with/without oxygen to optimize MRI image quality. | Other | Functional Residual Capacity/End-Expiration With Oxygen, Functional Residual Capacity/End-Expiration Without Oxygen |
Primary outcome
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).
3 secondary outcomes
Breath-Holding Duration
Time frame: During the MRI session (approximately 1 hour)
Oxygen Saturation During Breath-Holding
Time frame: During the MRI session (approximately 1 hour)
Adverse Events and Participant-Reported Discomfort
Time frame: During and immediately after the MRI session (up to 1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 26807896Yoo 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.
- Background: PubMed 30835515Vu 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.
- Background: PubMed 37207259Towell 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.
- Background: PubMed 27168468Parkes 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.
- Background: PubMed 31778311Khot 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.
- Background: PubMed 25555833Funk 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.
- Background: PubMed 26146869Chandarana 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John P Roberts, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath-hold conditions in people with MRI and MRI Image Enhancement, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John P Roberts, MD (415-353-3677, John.Roberts@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver MRI Image Quality (Motion Artifacts) (time frame: During the single MRI session (approximately 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07135401, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.