Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading
研究概览
简要总结
This pilot clinical trial compares gadobutrol with standard of care contrast agents, gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the central nervous system. It is not yet known whether gadobutrol is more effective than standard of care contrast agents before DCE-MRI in diagnosing patients with multiple sclerosis, grade II-IV glioma, or tumors that have spread to the brain.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether Gadavist® (gadobutrol) is consistent with Magnevist® (gadopentetate dimeglumine) or Multihance (gadobenate dimeglumine) in the preoperative grading of gliomas utilizing DCE MRI.
II. To determine whether Gadavist® is consistent with Magnevist® or Multihance in identifying the number of cerebral metastases from a primary cancer elsewhere in the body using T1-weighted post contrast MRI.
III. To determine if Gadavist® is consistent with Magnevist® or Multihance in identifying multiple sclerosis (MS) plaques using T1-weighted post contrast MRI.
IV. To determine if Gadavist® produces similar MR perfusion/permeability values of MS lesions as Magnevist® or Multihance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Confirmed diagnosis of multiple sclerosis, known or suspected diagnosis of glioma, or known or suspected diagnosis of cerebral metastasis
- •Scheduled or to be scheduled for a follow-up MRI per standard of care for their disease
- •Minimum permitted time intervals from prior treatments are 6 weeks for intracranial surgery
- •Adequate renal function (serum creatinine =< 1.5 mg/dL)
- •Subject must sign a study-specific informed consent
排除标准
- •Medically unstable
- •Renal impairment (glomerular filtration rate [GFR] < 60 mL/min/1.73m^2) or history of existing nephrogenic systemic fibrosis (NSF)
- •Cardiac pacemaker
- •A serious concurrent infection, illness, or medical condition
- •Subjects with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
- •Subject is claustrophobic and cannot cooperate for the MRI
- •Females who are pregnant or nursing
- •Any other condition that would compromise the scan with reasonable safety
研究组 & 干预措施
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
Patients receive standard of care gadopentetate dimeglumine IV twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
Patients receive standard of care gadopentetate dimeglumine IV twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7.
干预措施: Gadobenate Dimeglumine (Drug)
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
Patients receive standard of care gadopentetate dimeglumine IV twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7.
干预措施: Gadobutrol (Drug)
Diagnostic (Magnevist/Multihance, Gadavist, DCE-MRI)
Patients receive standard of care gadopentetate dimeglumine IV twice within 5 minutes or gadobenate dimeglumine IV twice within 5 minutes and then undergo DCE-MRI on day 1. Patients also receive gadobutrol IV twice within 5 minutes and then undergo DCE-MRI over approximately 30 minutes on day 3, 4, 5, 6, or 7.
干预措施: Gadopentetate Dimeglumine (Radiation)
结局指标
主要结局
Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading
时间窗: Up to 7 days
Weighted Kappa analysis will be used to examine the agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading.
次要结局
未报告次要终点