NCT02095353终止不适用
Gadobenate Dimeglumine Compared to Gadobutrol for MRI Perfusion Analysis in Brain Tumor Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Degree of contrast induced signal changes with dynamic imaging of brain tumors
研究概览
简要总结
This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.
详细描述
This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor.
排除标准
- •Renal failure (GFR <45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines.
- •Allergic reactions to MRI contrast agents.
- •Subjects who do not fit the criteria for the population we are evaluating.
- •Subjects should not participate in this study if they have any of the following conditions:
- •Anxiety attacks
- •Panic disorder
- •Claustrophobia
- •Pregnant, or trying to become pregnant
- •Breast feeding
- •Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects.
- •If a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical MRI examination to safely perform the research MRI examination that subject would be excluded.Subjects not being able to return for a follow-up examination
结局指标
主要结局
Degree of contrast induced signal changes with dynamic imaging of brain tumors
时间窗: 2 weeks
Two contrast agents will be administered in different MRI imaging sessions. Will measure how the appearance of brain tumors change during dynamic first pass contrast administration.
次要结局
- Calculate differences in cerebral blood volume, ktrans and flow in brain tumors(2 weeks)
研究者
研究点 (1)
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