Phase IV, Double Blind, Multi-Center, Randomized, Two-Arm Crossover Study to Compare 0.1 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem and 0.05 mmol/kg of MultiHance With 0.1 mmol/kg of Dotarem in MRI of the Brain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Global Diagnostic Preference Between the Two Exams
研究概览
简要总结
This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.
详细描述
This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Are at least 18 years of age or older
- •Are able to give written informed consent and are willing to comply with the protocol requirements
- •Are scheduled to undergo MRI
- •Are willing to undergo two MRI procedures within 14 days
- •Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
- •Clinical/neurological symptomatology;
- •Diagnostic testing, such as CT or previous MRI examinations; or
- •Have had recent brain surgery and are to be evaluated for recurrence
排除标准
- •Are pregnant or lactating females. Exclude the possibility of pregnancy:
- •By testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
- •By history (i.e., tubal ligation or hysterectomy); or
- •Post menopausal with a minimum of 1 year without menses
- •Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
- •Have congestive heart failure (class IV according to the classification of the New York Heart Association)
- •Have suffered a stroke within a year
- •Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2
- •Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product
- •Have moderate-to-severe renal impairment, defined as Glomerular Filtration Rate (GFR)/estimated GFR < 45 mL/min
- •Have been previously entered into this study
- •Have received or are scheduled for one of the following:
- •Surgical or chemotherapeutic treatment within three weeks prior to the first examination or between the two examinations
- •Initiation of steroid therapy between the two examinations
- •Radiosurgery between the two examinations
- •Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field
- •Are suffering from severe claustrophobia
- •Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
研究组 & 干预措施
MultiHance 0.1 then Dotarem 0.1 mmol/kg
MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg
干预措施: MultiHance 0.1 mmol/kg (Drug)
MultiHance 0.1 then Dotarem 0.1 mmol/kg
MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg
干预措施: Dotarem (Drug)
MultiHance 0.05 then Dotarem 0.1 mmol/kg
MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg
干预措施: Dotarem (Drug)
MultiHance 0.05 then Dotarem 0.1 mmol/kg
MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg
干预措施: MultiHance 0.05 mmol/kg (Drug)
Dotarem 0.1 then MultiHance 0.1 mmol/kg
Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg
干预措施: MultiHance 0.1 mmol/kg (Drug)
Dotarem 0.1 then MultiHance 0.1 mmol/kg
Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg
干预措施: Dotarem (Drug)
Dotarem 0.1 then MultiHance 0.05 mmol/kg
Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg
干预措施: Dotarem (Drug)
Dotarem 0.1 then MultiHance 0.05 mmol/kg
Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg
干预措施: MultiHance 0.05 mmol/kg (Drug)
结局指标
主要结局
Global Diagnostic Preference Between the Two Exams
时间窗: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.
次要结局
- Lesion Border Delineation(Comparison of image sets obtained within 2 to 14 days)
- Lesion Internal Morphology(Comparison of image sets obtained within 2 to 14 days)
- Extent of Disease(Comparison of image sets obtained within 2 to 14 days)
- Lesion Contrast Enhancement(Comparison of image sets obtained within 2 to 14 days)
- Lesion to Background Ratio on Post T1-weighed Spin Echo Images(5-10 minutes Postdose)
- Lesion-brain Contrast-to-noise Ratio(5-10 minutes Postdose)