NL-OMON54381招募中不适用
Safety, tolerability, efficacy and pharmacokinetic study of increasing doses of B26826 in adult patients with known or suspected intracranial lesions referred for contrast-enhanced MRI of the brain. - FIH study with a new contrast medium (B26826) for Magnetic Resonance.
Bracco Imaging S.pA.0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Provides written Informed Consent and is willing to comply with protocol
- •requirements;
- •Male and female between 18 and 75 years of age inclusive;
- •Is referred for and has been scheduled to undergo a contrast-enhanced MRI
- •examination of the brain;
- •Has a Karnofsky Performance Score >=70.
排除标准
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy: • by
- •testing on site at the institution (serum βHCG) within 24 hours prior to the
- •start of Gadovist(r) administration, • by surgical history (e.g., tubal
- •ligation or hysterectomy), • post-menopausal with a minimum 1 year without
- •menses; • Has any known allergy to GBCAs; • 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 Gadovist(r)
- •injection through 7 days following B26826 administration; • 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 7 days
- •post-administration of B26826; • Suffers from mild-to-severe chronic kidney
- •disease (estimated glomerular filtration rate < 60 mL/min/1.73 m2
- •calculating using the abbreviated MDRD formula); • Has, in the previous 7 days
- •before the first MRI with Gadovist® (0.1 mmolGd/kg) through B26826
- •administration, received prescription or non-prescription systemic medications
- •(e.g., anticancer drugs, barbiturates, or phenothiazines) which, in the opinion
- •of the Investigator, may interfere with the study procedure or affect safety
- •and efficacy assessments; • Has received or are scheduled for one of the
- •following: • Surgical, radiation or chemotherapeutic treatment within one weeks
- •prior to the first examination or between the two examinations; • initiation of
- •steroid therapy between the two examinations; • Has any contraindications to
- •MRI such as a pacemaker, magnetic material (i.e., surgical clips) or any other
- •conditions that would preclude proximity to a strong magnetic field • Are
- •suffering from severe claustrophobia; • Has participated in a clinical trial of
- •an investigational drug and/or medical device within 3 months before admission
- •into this study; • Has 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; •
- •Cannot reliably communicate with the Investigator or is not likely to
- •co-operate with the requirements of the study.
研究者
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