EUCTR2006-000206-23-CZ进行中（未招募）不适用
PHASE IV, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, CROSSOVER STUDY TO COMPARE 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® IN MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN (MERIT) - MERIT
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject who:
- •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
- •Subjects who 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 surgery within 6 months and are to be evaluated for recurrence.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who:
- •Are pregnant or lactating females. Exclude the possibility of pregnancy:
- •- by testing on site at the institution (serum or urine ßHCG) within 24 h prior to the start of each investigational product administration
- •- by history (i.e., tubal ligation or hysterectomy)
- •- post menopausal with a minimum of 1 year without menses
- •Have any known allergy to one or more of the ingredients in the investigational product, 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 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h 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 h post-administration of the second investigational product.
- •Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 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
- •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
研究者
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