Optimizing MRI Liver Imaging: Evaluating Breath-Holding Techniques and Oxygen Supplementation to Reduce Respiratory Motion Artifacts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Liver MRI Image Quality (Motion Artifacts)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Functional Residual Capacity/End-Expiration Without Oxygen
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.
干预措施: Breath-hold conditions (Other)
Functional Residual Capacity/End-Expiration With Oxygen
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.
干预措施: Breath-hold conditions (Other)
结局指标
主要结局
Liver MRI Image Quality (Motion Artifacts)
时间窗: 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).
次要结局
- 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))