Breast MRI Screening in High-Risk Women After Mantle Radiation Therapy for Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of breast cancer detected with addition of breast MRI
研究概览
简要总结
Objectives:
The objective of this single-arm, prospective study is to perform annual mammography and MRI breast cancer screening in women who underwent mantle-field irradiation between 1970-1995 at M. D. Anderson Cancer Center in order to compare the ability of MRI and standard mammography to identify breast cancer. In addition, we will determine whether the combination of breast MRI and mammography identifies smaller, earlier-stage tumors, which would lead to improved cure rates. We will also take the opportunity to determine the incidence and stage of breast cancer in this high-risk cohort.
详细描述
Breast MRIs:
Breast MRIs have been reported to have higher sensitivity than mammograms for detecting early breast cancers, particularly in dense breasts where mammograms are not as effective. Although breast MRIs may add important information not provided by mammograms, the MRI must be used selectively. This is because the MRI is very sensitive and may show a false positive test (a test that shows cancer when there is none there).
Study Procedures:
If you are found to be eligible to take part in this study, the following procedures will be performed 1 time a year.
- You will have a breast exam.
- You will have a mammogram. A mammogram is a breast x-ray used to detect breast cancer and look for abnormalities in the breast.
- You will have an MRI of your breasts. For the MRI, you will lay on your stomach while a large donut-shaped scanner takes images of your breasts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with lymphoma prior to 1995
- •The radiation therapy must have been delivered at M.D. Anderson from start to finish with complete records of dose received
- •Patients must have received radiation therapy to the chest between the ages of 10 and 30
排除标准
- •Patients with claustrophobia
- •Obese patients (the equipment weight limit is 350 pounds and the maximum scanner bore diameter is 55 cm)
- •Patients with myocardial infarction within 6 months of study entry
- •Patients with unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled arrhythmias
- •Patients with aneurysm clips, pacemakers, or other implanted devices that are not MRI compatible
- •Pregnant patients
- •Patients with compromised renal function, with a calculated glomerular filtration rate (cGFR) less than 60 ml/min/1.73m
- •Patients who began their treatment outside of MD Anderson Cancer Center.
结局指标
主要结局
Incidence of breast cancer detected with addition of breast MRI
时间窗: Once a year
次要结局
未报告次要终点