Optimizing Liver MRI Using Breath-Holding With and Without Oxygen

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Liver MRI Image Quality (Motion Artifacts) [Срок оценки: During the single MRI session (approximately 1 hour)]

Вторичные конечные точки (3)

• Breath-Holding Duration [Срок оценки: During the MRI session (approximately 1 hour)]
• Oxygen Saturation During Breath-Holding [Срок оценки: During the MRI session (approximately 1 hour)]
• Adverse Events and Participant-Reported Discomfort [Срок оценки: During and immediately after the MRI session (up to 1 hour)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Публикации

• 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 26807896
• 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 30835515
• 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 37207259
• 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 27168468
• 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 31778311
• 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 25555833
• 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 26146869

Идентификаторы

NCT: NCT07135401 · 25-44459

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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