NCT00165412已完成不适用
Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- To compare the sensitivity, specificity, positive and negative predictive value of mammography and breast MRI for breast cancer detection in women treated for Hodgkin's disease.
研究概览
简要总结
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.
详细描述
- The screening breast MRI and mammography will be performed 6 months or longer after the last mammogram. For pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. As much as possible, the breast MRI and mammogram are to be performed on the same day.
- On the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc.
- In patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients treated with radiation therapy to the chest area for Hodgkin's disease
- •Age between 12 and 35 at initial treatment
- •Eight years or longer after initial treatment
- •Pre-approval from the participant's insurance company for the breast imaging studies
排除标准
- •Pregnant or lactating women
- •Post Bilateral mastectomy
- •Currently undergoing breast cancer therapy
- •Known metastatic cancer
- •Patients with contraindications for undergoing an MRI: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.
结局指标
主要结局
To compare the sensitivity, specificity, positive and negative predictive value of mammography and breast MRI for breast cancer detection in women treated for Hodgkin's disease.
时间窗: 5 years
次要结局
- To describe the MRI appearance and enhancing characteristics of breast cancer after Hodgkin's disease(5 years)
- to correlate the breast MRI findings and pathological findings(5 years)
- to determine the incidence of interval breast cancer in the screened population.(5 years)
研究者
Andrea K. Ng, MD
Radiation Oncologist
Dana-Farber Cancer Institute
研究点 (3)
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