A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
研究概览
简要总结
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 2 and 17 years of age
- •Informed consent from parents
- •Assent from patient where required
- •Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination
排除标准
- •Contraindication to MRI
- •Undergoing MRI in an emergency situation
- •Known allergy to one or more of the ingredients in MultiHance
- •Sickle cell anemia moderate to severe renal impairment
- •Received another investigational compound within 30 days
- •Pregnancy
- •Lactating females
- •Likely to undergo an invasive procedure within 72 hours of receiving MultiHance
研究组 & 干预措施
Gadobenate Dimeglumine
干预措施: gadobenate dimeglumine (Drug)
结局指标
主要结局
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
时间窗: pre-dose and immediately postdose
5-point scale (0=no delineation of lesion borders \[lesion not identified in image, lesion borders not visible\]; 1=poor border delineation \[all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema\]; 2=moderate border delineation \[border delineation fair/not complete, lesion not clearly separated\]; 3=good border delineation \[border delineation complete, lesion adequately separated\]; 4=excellent border delineation \[borders sharply/clearly distinct, lesion sharply separated\]) paired assessment to compare the difference between pre to pre+postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
时间窗: pre-dose and immediately postdose
5-point scale (0=no delineation of lesion borders \[lesion not identified in image, lesion borders not visible\]; 1=poor border delineation \[all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema\]; 2=moderate border delineation \[border delineation fair/not complete, lesion not clearly separated\]; 3=good border delineation \[border delineation complete, lesion adequately separated\]; 4=excellent border delineation \[borders sharply/clearly distinct, lesion sharply separated\]) paired assessment to compare the difference between pre to pre+postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
时间窗: pre-dose and immediately postdose
5-point scale (0=no delineation of lesion borders \[lesion not identified in image, lesion borders not visible\]; 1=poor border delineation \[all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema\]; 2=moderate border delineation \[border delineation fair/not complete, lesion not clearly separated\]; 3=good border delineation \[border delineation complete, lesion adequately separated\]; 4=excellent border delineation \[borders sharply/clearly distinct, lesion sharply separated\]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
时间窗: pre-dose to immediately post dose
5-point scale (0=no visualization of lesion internal morphology (LIM) \[lesion not identified in image, not visible\]; 1=poor visualization of LIM \[insufficiently depicted, intralesional features poorly identified\]; 2=moderate visualization of LIM \[not completely depicted, some intralesional features visible\]; 3=good visualization of LIM \[completely depicted, intralesional features adequately identified\]; 4=excellent visualization of LIM \[optimally depicted, intralesional features clearly identified and characterized\]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
时间窗: pre-dose to immediately post dose
5-point scale (0=no visualization of lesion internal morphology (LIM) \[lesion not identified in image, not visible\]; 1=poor visualization of LIM \[insufficiently depicted, intralesional features poorly identified\]; 2=moderate visualization of LIM \[not completely depicted, some intralesional features visible\]; 3=good visualization of LIM \[completely depicted, intralesional features adequately identified\]; 4=excellent visualization of LIM \[optimally depicted, intralesional features clearly identified and characterized\]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
时间窗: pre-dose to immediately postdose
5-point scale (0=no visualization of lesion internal morphology (LIM) \[lesion not identified in image, not visible\]; 1=poor visualization of LIM \[insufficiently depicted, intralesional features poorly identified\]; 2=moderate visualization of LIM \[not completely depicted, some intralesional features visible\]; 3=good visualization of LIM \[completely depicted, intralesional features adequately identified\]; 4=excellent visualization of LIM \[optimally depicted, intralesional features clearly identified and characterized\]) paired assessment to compare the difference between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
时间窗: pre-dose and immediately postdose
5-point scale (0=no lesion CE \[lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue\]; 1=poor lesion CE \[diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size\]; 2=moderate lesion CE \[diff. in SI fair, lesion identified, not possible to evaluate/measure size\]; 3=good lesion CE \[diff. in SI adequate, lesion identified, size evaluated/measured\]; 4=excellent lesion CE \[diff. in SI marked, lesion identified, size measured\]) paired assessment to compare the diff. between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
时间窗: pre-dose to immediately postdose
5-point scale (0=no lesion CE \[lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue\]; 1=poor lesion CE \[diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size\]; 2=moderate lesion CE \[diff. in SI fair, lesion identified, not possible to evaluate/measure size\]; 3=good lesion CE \[diff. in SI adequate, lesion identified, size evaluated/measured\]; 4=excellent lesion CE \[diff. in SI marked, lesion identified, size measured\]) paired assessment to compare the diff. between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
时间窗: pre-dose to immediately postdose
5-point scale (0=no lesion CE \[lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue\]; 1=poor lesion CE \[diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size\]; 2=moderate lesion CE \[diff. in SI fair, lesion identified, not possible to evaluate/measure size\]; 3=good lesion CE \[diff. in SI adequate, lesion identified, size evaluated/measured\]; 4=excellent lesion CE \[diff. in SI marked, lesion identified, size measured\]) paired assessment to compare the diff. between pre to pre+postdose
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
时间窗: up to 72 hours post dose
次要结局
未报告次要终点