Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 229
- 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 direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
详细描述
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.
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 scheduled to undergo MRI
- •Are willing to undergo two MRI procedures within 14 days
- •Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
- •Clinical/neurological symptomatology;
- •Diagnostic testing, such as CT or previous MRI examinations; or
- •Have had previous 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; see Appendix A)
- •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 a GFR/eGFR < 45 mL/min.
- •Have been previously entered into this study
- •Have received or are scheduled for one of the following:
- •Surgery 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
研究组 & 干预措施
MRI with Gadoteridol
MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences.
干预措施: gadoteridol (Drug)
MRI with Gadoteridol
MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences.
干预措施: gadobutrol (Drug)
MRI with Gadobutrol
MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.
干预措施: gadoteridol (Drug)
MRI with Gadobutrol
MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.
干预措施: gadobutrol (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 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
次要结局
- Extent of Disease(Comparison of image sets obtained within 2 to 14 days)
- Percentage Signal Intensity Enhancement on Postdose Images(5-10 minutes Postdose)
- Lesion Border Delineation(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 Internal Morphology(Comparison of image sets obtained within 2 to 14 days)
- Accuracy for Tumor Characterization(5-10 minutes Postdose)
- Lesion Detection(5-10 minutes Postdose)