Multi-center, Randomized, Controlled, Single-blind, Intra-individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 165
- 主要终点
- Number of Lesions Detected by Blinded Readers (BR) and Investigator
研究概览
简要总结
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients at least 20 years of age
- •Patients with diagnosed primary cancer
- •Patients with metastatic lesions by CT/MRI
排除标准
- •Patients who have contraindication to the MRI examinations
- •Patients who have severe renal disorder
- •Patients in extremely serious general condition
研究组 & 干预措施
Gadobutrol 0.1 mmol/kg bw
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
干预措施: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
Gadobutrol 0.2 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
干预措施: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
Gadoteridol (ProHance)
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
干预措施: ProHance (Drug)
结局指标
主要结局
Number of Lesions Detected by Blinded Readers (BR) and Investigator
时间窗: one day
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
次要结局
- Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator(one day)
- Score of Visibility Assessment - Border Delineation by Investigator(one day)
- Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)(one day)
- Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator(one day)
- Lesion Size Evaluated by Independent Radiologist(one day)
- Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader(one day)
- Score of Visibility Assessment - Border Delineation by Blinded Reader(one day)
- Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator(one day)
- Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE(one day)
- Number of Participants With Reasons for Performance in SRS Planning by TPE(one day)
- Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator(one day)
- Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions(one day)
- Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist(one day)
- Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE(one day)
- Number of Participants With Reasons for Performance in SRS Planning by Investigator(one day)