Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 主要终点
- Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)
研究概览
简要总结
The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.
详细描述
70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female over 21 years of age;
- •with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
- •and in good health (other than having breast lesions);
- •and can lie still in a prone position for 30 minutes in an MRI scanner.
排除标准
- •Pregnancy;
- •unwilling to give informed consent;
- •have implanted prosthetic heart valve,
- •pacemaker,
- •neurostimulator,
- •surgical clips or other metallic implants;
- •have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
- •are claustrophobic;
- •have been allergic to contrast agents;
- •are diabetic;
- •or have a history of kidney disease.
结局指标
主要结局
Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)
时间窗: up to 2 years
Patients with benign disease on biopsy may be followed for up to 2 years after imaging
次要结局
未报告次要终点