NCT01092754已完成4 期
An Open-Label, Multicenter, Phase 4 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark(R) in Pediatric Patients (2-11 & 12-18 Yrs) Referred for Contrast-Enhanced MRI
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.
研究概览
简要总结
The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.
详细描述
Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 thru 18 years of age
- •referred for MRI of the liver or CNS
- •if female and of child-bearing potential, must have negative pregnancy test within 24 hours of study drug administration
- •if applicable, agree to use medically accepted method of contraception throughout the study
- •if necessary, patients entering the PK subgroup must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration
- •understand the requirements of the study and provide written consent to participate, agree to abide by the study requirements
排除标准
- •previously entered into this study or a previous study using Optimark
- •received investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period. (patients on a research protocol using an approved drug ar acceptable)
- •medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance and all prescribed follow up
- •known or suspected abnormal renal function for age or requiring dialysis during the study period
- •pregnant or breastfeeding
- •scheduled to undergo any contrast-enhanced examination within 7 days prior to baseline examination or during the course of this study period
- •condition that is a contraindication to MRI (i.e., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other condition that would preclude patient proximity to a strong external magnetic field)
- •experienced a previous hypersensitivity reaction to a gadolinium-based contrast agent
- •recent history of hemolytic anemia, sickle cell anemia, or other hemoglobinopathy
- •undergone a surgical procedure within one week prior to study admission or are planned to undergo a surgical procedure during study participation (central line placement is acceptable)
- •history of significant claustrophobia
- •weighs less than 25 lbs (11 kgs)
研究组 & 干预措施
A: Other
Other
干预措施: MRI (Procedure)
A: Other
Other
干预措施: Gadoversetamide (Drug)
B: Other
Other
干预措施: MRI (Procedure)
B: Other
Other
干预措施: Gadoversetamide (Drug)
结局指标
主要结局
Assess efficacy by analyzing the clinical diagnosis, degree of confidence in diagnosis and level of conspicuity of lesions.
时间窗: Immediately before and immediately after Optimark dosing
Optimark is an MRI contrast. Efficacy measurements will be determined from images obtained without contrast (immediately before) and with contrast (immediately after).
次要结局
- Assess the blood and urine PK levels of Optimark(through 10 hours post dose)
- Assess the safety of Optimark by analyzing adverse events and changes in vital signs, electrocardiograms (ECGs), physical exams, and clinical laboratory results.(through 24 hours post dose)
研究者
研究点 (12)
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