Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Hyperfine
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Radiologist-rated lesion border delineation on post-contrast portable MRI
研究概览
简要总结
This is a prospective, multi-center, interventional study designed to evaluate the visualization benefits of FDA approved gadolinium-based contrast agents (GBCAs) in portable magnetic resonance imaging (pMRI) of the brain. The study will enroll adult patients with known or suspected brain lesions involving blood-brain barrier disruption. Each participant will undergo a pre-contrast pMRI scan, receive an intravenous GBCA injection, and then complete a post-contrast pMRI scan using the Swoop® Portable MR Imaging® System. Lesion visualization will be assessed by independent neuroradiologists using standardized scoring criteria. The study will be conducted across a minimum of three sites to ensure diversity in patient population, imaging environments, and GBCA types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, an individual must meet all the following criteria:
- •Age ≥18 years Clinical indication of suspected or known brain lesion(s) with focal blood-brain barrier disruption. Preferably, at least one previously documented brain lesion with focal areas of blood-brain barrier disruption categorizable as:
- •intra-axial tumor(s)
- •extra-axial tumor(s)
- •infection/inflammatory lesion(s)
- •Cleared for portable MRI (pMRI) and intravenous GBCA administration per site policy.
- •Adequate peripheral venous access for contrast injection.
- •Able to provide informed consent and comply with brief supine imaging (pre- and post-contrast)
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Metallic clips or devices in the brain or eye.
- •Body weight greater than 200 kg.
- •Inability to fit or be positioned appropriately within the Swoop® Portable MR Imaging® System.
- •Inability to remain still or lie flat during the imaging period.
- •Not cleared for GBCA administration due to known hypersensitivity, allergy, or contraindication.
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or acute kidney injury.
- •History of severe reaction to any gadolinium-based contrast agent.
- •GBCA administration within the prior 48 hours (or alternative clearance window defined by institution)
- •Known or suspected pregnancy at the time of imaging.
- •Any medical or behavioral condition that, in the investigator's judgment, would make participation unsafe or interfere with study completion.
- •Subjects may be selectively enrolled or excluded to ensure inclusion of radiology finding subgroups and GBCA agents.
研究组 & 干预措施
Single-Arm: Pre- and Post-Contrast pMRI
Participants will undergo portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T), including imaging performed before and after intravenous administration of an FDA-approved gadolinium-based contrast agent (GBCA).
干预措施: Portable MRI (pMRI) (Device)
Single-Arm: Pre- and Post-Contrast pMRI
Participants will undergo portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T), including imaging performed before and after intravenous administration of an FDA-approved gadolinium-based contrast agent (GBCA).
干预措施: Gadolinium-Based Contrast Agent (GBCA) (Drug)
结局指标
主要结局
Radiologist-rated lesion border delineation on post-contrast portable MRI
时间窗: 6 months
Blinded neuroradiologists will assess lesion border delineation on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = poor delineation, 5 = excellent delineation). Scores will be summarized using descriptive statistics.
Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI
时间窗: 6 months
Blinded neuroradiologists will evaluate the visibility of lesion internal morphology on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = non-visible, 5 = clearly visible). Scores will be summarized using descriptive statistics.
Radiologist-rated degree of contrast enhancement of target lesions on portable MRI
时间窗: 6 months
Blinded neuroradiologists will rate the degree of lesion contrast enhancement on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = no enhancement, 5 = marked enhancement). Ratings will be summarized descriptively across subjects.
Radiologist-rated lesion border delineation on post-contrast portable MRI
时间窗: 6 months
Blinded neuroradiologists will assess lesion border delineation on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = poor delineation, 5 = excellent delineation). Scores will be summarized using descriptive statistics.
Radiologist-rated lesion internal morphology visibility on post-contrast portable MRI
时间窗: 6 months
Blinded neuroradiologists will evaluate the visibility of lesion internal morphology on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = non-visible, 5 = clearly visible). Scores will be summarized using descriptive statistics.
Radiologist-rated degree of contrast enhancement of target lesions on portable MRI
时间窗: 6 months
Blinded neuroradiologists will rate the degree of lesion contrast enhancement on post-contrast T1-weighted portable MRI images using a standardized 5-point Likert scale (1 = no enhancement, 5 = marked enhancement). Ratings will be summarized descriptively across subjects.
次要结局
未报告次要终点