NCT02035852已完成不适用
High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Benefit of 7T MR imaging
研究概览
简要总结
The study will compare two different size MRI's of a brain tumor.
详细描述
The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female, age 18 years or older
- •Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
- •Histological diagnosis of a brain tumor
- •Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
- •Pre-operative brain MR imaging suggestive of a brain tumor
- •Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)
- •Patient able and willing to provide informed consent
- •Karnofsky Performance status > 70%
- •Life expectancy greater than 3 months
- •Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
- •Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T * Spanish speaking participants will be enrolled for this study
排除标准
- •Body weight >137 Kg (300 lbs)
- •Patient unable to provide informed consent
- •Karnofsky Performance status < 70%
- •Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
- •NYHA class III and IV congestive heart failure
- •Psychiatric or addictive disorders that preclude obtaining informed consent
- •Unstable angina
- •Sexually active patients of childbearing potential not using a reliable contraceptive method
- •Pregnant or lactating women
- •Women of childbearing potential who refuse a pregnancy test (performed during screening)
结局指标
主要结局
Benefit of 7T MR imaging
时间窗: Baseline and 6 month intervals after baseline
1. To determine the benefit of 7T MR imaging in brain tumor patients with regard to the improvement in resolution, as measured by the area of T2 FLAIR signal abnormality and the ability to detect abnormalities in vascular integrity. The benefit will be determined at a single time point as well as longitudinally for each patient at 6 month intervals.
次要结局
- Vascular Integrity(Every 6 months, up to 12 months.)
研究者
研究点 (1)
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