Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Best diagnostic performance of computed tomography (CT) reconstruction parameters
研究概览
简要总结
This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.
详细描述
PRIMARY OBJECTIVES:
I. To optimize two major parameters of computed tomography (CT) imaging for optimal detection of intracranial metastatic lesions.
Ia. Virtual monochromatic image reconstruction. Ib. Contrast bolus timing. II. To measure the detection accuracy of CT compared to the diagnostic standard of care gadolinium-based "Gamma Knife (GK)" protocol magnetic resonance imaging (MRI).
OUTLINE:
Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.
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
- •Adult patient with pathology-proven solid organ cancer
- •MRI of the brain with contrast, positive for two or more metastatic lesions
- •One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater
- •Planned treatment with stereotactic radiosurgery
排除标准
- •Known allergy to iodine-based contrast agents
- •Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis
- •If prior nephrectomy, GFR less than 60
- •Prior central nervous system malignancy
- •Prior brain radiation
- •Pregnant women are excluded
结局指标
主要结局
Best diagnostic performance of computed tomography (CT) reconstruction parameters
时间窗: Up to 2 years
A repeated-measures analysis of variance with the Dunnett post hoc test will be used to determine the significance of the differences in the signal-to-noise (SNR) and contrast-to-noise (CNR) measurements at the optimal parameter setting, compared with all other parameter settings.
Accuracy of CT
时间窗: Up to 2 years
A Bland-Altman analysis will be used to show the agreement of number of lesions between optimal parametrized CT and the one of standard of care magnetic resonance imaging (MRI).
次要结局
未报告次要终点