Can MRI Replace CT in the Evaluation of Thymoma?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Accuracy of magnetic resonance imaging (MRI) staging
研究概览
简要总结
This trial studies the accuracy of a magnetic resonance imaging (MRI) scan in imaging the inside of the chest in patients with thymoma that is newly diagnosed or has come back. An MRI scan may be able to detect if and how far the tumor has spread more accurately than a standard computed tomography (CT) scan.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether thymoma staging by MRI is as accurate as staging by CT as compared to surgical staging.
SECONDARY OBJECTIVES:
I. To determine whether evaluation of phrenic nerve paralysis by functional MRI is as accurate as the fluoroscopic "sniff test" as compared to surgical evaluation of phrenic nerve involvement.
II. To determine whether fast novel MRI sequences are as accurate as conventional MRI sequences for staging thymoma, when comparing to surgical staging.
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
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
- •All adult patients scheduled to meet with a thoracic surgeon from MD Anderson Cancer Center (ACC) for resection of newly diagnosed thymoma or thymoma recurrence in the chest and scheduled for surgery
排除标准
- •Children, defined as individuals younger than 18 years old on the preoperative visit with the thoracic surgeon
- •Pregnant patients
- •Patients unable to understand the consent form
- •Patients with metal within the chest and pacemakers
- •Patients with a known allergic reaction to gadolinium, who will have their MRI performed without contrast
- •Patients with glomerular filtration rate (GFR) < 60 ml/min, who will have their MRI performed without contrast
- •Patients with an allergy to iodinated contrast material will follow departmental routine policy, that is those with anaphylaxis will have their CT performed without intravenous contrast and others will be prepped as for departmental guidelines for routine chest CT
- •Patients with abnormal renal function will have their CT study perform as per DI's iodinated contrast administration guidelines, and no contrast will be administered with GFR lower than 30 ml/min
研究组 & 干预措施
Diagnostic (MRI, diaphragm fluoroscopy)
Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
干预措施: Diaphragm Fluoroscopy (Procedure)
Diagnostic (MRI, diaphragm fluoroscopy)
Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Accuracy of magnetic resonance imaging (MRI) staging
时间窗: Up to 10 years
Will be compared to staging done by computed tomography (CT). McNemar's test will be used to compare the accuracy for the following five sets of comparisons: spin echo (SE) T1 compared versus (vs.) liver acquisition with volume acquisition (LAVA)+ in-phase (IP)/out-of-phase (OP), Dixon versus fast spin echo (FSE) T2, LAVA+IP/OP+Dixon vs. SET1+FSET2, LAVA+IP/OP+Dixon vs. computed tomography (CT) scan, and SET1+FSET2 vs. CT scan. A p value less than 0.05 will be defined as significant. A p value less than 0.05 will be defined as significant.
次要结局
- Accuracy of phrenic nerve paralysis by functional MRI(Up to 10 years)
- Accuracy of fast novel MRI sequences(Up to 10 years)