Evaluate Artificial Intelligence (AI) Synthesized MR Images From Low Dose Gadobutrol CNS Images vs Standard Dose Gadobutrol CNS Images
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Compare enhancement of SubtleGAD in 10% dose and 25% dose gadobutrol MR images.
研究概览
简要总结
Study 22403 is a Phase 1 / Proof of Concept exploratory investigation to assess the non-inferiority of low dose gadobutrol and SubtleGAD™, a software medical device using an Artificial Intelligence (AI) deep learning-based method to enhance the contrast signal from images acquired with low dose administration of gadobutrol (GAD) contrast. The primary objective is to demonstrate noninferiority of synthesized Central Nervous System (CNS) magnetic resonance (MR) images for 1 or 2 different gadobutrol-enhanced low-dose groups (0.01mmol/kg, and0.025 mmol/kg) compared to gadobutrol-enhanced CNS MR images at a standard dose of 0.1 mmol/kg. This investigation is a prospective, randomized, open label, multi-center study with blinded reads in participants with known or highly suspected CNS pathology. There will be at least 60 participants enrolled (30 per study arm). SubtleGAD will be used as a post-processing tool, prior to blinded read assessment of MR images acquired in either arm of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of signing the informed consent at least 18 years of age and less than or equal to 89 years of age.
- •Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS.
- •Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^
- •Be fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and being capable and willing to consent to participate.
排除标准
- •Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.
- •Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up.
- •Brain pathology or abnormalities that are not considered lesions.
- •Any contraindication for MRI procedure or gadobutrol administration.
- •Has severe cardiovascular disease.
- •Is expected or is scheduled to have a change in any treatment or procedure between the two study periods that may alter image comparability.
- •Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 24 hours after the second study MRI.
- •Women currently lactating, pregnant, or planning on becoming pregnant during the study.
- •Women of childbearing potential with a positive urine pregnancy test within 24 hours before either gadobutrol administration.
- •Receipt of any gadolinium-based contrast agent <72 hours prior to the study MRIs.
- •Participants with acute kidney injury.
研究组 & 干预措施
Group A (10% dose GV)
Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and 10% dose gadobutrol (0.01 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (10% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.
干预措施: SubtleGAD (Device)
Group A (10% dose GV)
Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and 10% dose gadobutrol (0.01 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (10% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.
干预措施: Gadobutrol (Drug)
Group B (25% dose GV)
Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and Study Period 2: 25% dose gadobutrol (0.025 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (25% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.
干预措施: SubtleGAD (Device)
Group B (25% dose GV)
Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and Study Period 2: 25% dose gadobutrol (0.025 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (25% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.
干预措施: Gadobutrol (Drug)
结局指标
主要结局
Compare enhancement of SubtleGAD in 10% dose and 25% dose gadobutrol MR images.
时间窗: 4 to 15 days
Compare enhancing lesions in gadobutrol-enhanced central nervous system (CNS) magnetic resonance imaging (MRI) low dose groups (0.01 mmol/kg, 0.025 mmol/kg), and standard dose (0.1 mmol/kg).
次要结局
未报告次要终点