Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 57
- 试验地点
- 17
- 主要终点
- Overall Diagnostic Preference
研究概览
简要总结
Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imaging which produces body pictures created by using magnetic energy rather than x-ray energy.
Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new GBCA under development with the goal to provide similar imaging performances in MRI. Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 - 14 days in between. A MRI examination will be performed after each injection. Participant will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is a one-way crossover study with blinded participants and blinded image readers
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
- •Participant must be at least 18 years of age at the time of signing the informed consent.
- •Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for contrast-enhanced MRI of the CNS.
- •Male and female.
- •Estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.
排除标准
- •Considered clinically unstable or has a concomitant/intercurrent condition (e.g. COVID-19 infection) that would not allow participation for the full planned study period (i.e. period 1, 2 or both) in the judgement of the investigator.
- •Severe cardiovascular disease.
- •Patients undergoing liver transplantation.
- •Any contraindication to MRI examinations.
- •History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents, foods, chemicals or other substances.
- •History of allergic asthma and/ or atopic dermatitis.
- •Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI:
- •Lepto-meningeal disease (e.g. leptomeningeal carcinomatosis). Dural lesions (e.g. meningiomas) fulfilling inclusion criteria #2 are not excluded
- •Pituitary adenomas (macro and micro)
- •Tumors of the choroid plexus
- •Tumors of the pineal gland
- •Dermoid/epidermoid tumors
- •Infectious disease (e.g. brain abscess, cisticercosis, etc.)
- •Venous angiomas
- •Subacute/chronic ischemia
- •Encephalitis
- •Multiple sclerosis (acute and chronic)
- •Optic neuritis
- •Chordomas
- •Von Hippel Lindau syndrome
- •Hypertensive leukoencephalopathy.
- •Receipt of any contrast agent < 72 h prior to the study MRIs, or planned receipt of any contrast agent within 72 h after the second study MRI.
- •Planned or expected biopsy in the region of interest or any interventional therapeutic procedure from the first study MRI up to 24 h after the second study MRI.
- •Planned or expected change in any treatment or procedure between the two study MRIs that may alter image comparability and /or chemotherapy which is changed between the two MRI procedures.
- •Contraindications to the administration of gadobutrol, as specified in the local product label.
研究组 & 干预措施
Gadobutrol + Gadoquatrane
Participants will receive one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) and one IV injection of Gadoquatrane (BAY1747846).
干预措施: Gadoquatrane (BAY1747846) (Drug)
Gadobutrol + Gadoquatrane
Participants will receive one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) and one IV injection of Gadoquatrane (BAY1747846).
干预措施: Gadobutrol (Gadovist/Gadavist) (Drug)
结局指标
主要结局
Overall Diagnostic Preference
时间窗: At 5 minute post each injection
Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken.
次要结局
- Sum of Lesion Visualization Parameters on Post-contrast Images(At 5 minute post each injection)
- Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images(At pre-injection and 5 minute post each injection)
- Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images(At pre-injection and 5 minute post each injection)
- Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images(At pre-injection and 5 minute post each injection)
- Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images(At pre-injection and 5 minute post injection)