A Multicenter Randomised Trial of Contrast-enhanced MR Imaging as a Breast Cancer Screening Tool Alternative to Mammography and Ultrasonography in Women at Intermediate Risk. Feasibility, and Short Term Results.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Rate of in situ and invasive breast cancers detected in the two arms of the study
研究概览
简要总结
A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer.
Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio to:
- Yearly two-view mammography (Mx) and breast ultrasonography (US) or
- Yearly MRI.
详细描述
Women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in Italy are based on mammography every two years starting at age 50.Women will be randomly assigned to Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 40-59 years with
- •cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). The lifetime cumulative risk of breast cancer will be computed using the IBIS Breast Cancer Risk Evaluation Tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. The evaluation of the composition of the mammary gland will be performed using the BI-RADS classification. Women with mammography in class 4 (i.e., >75% of glandular component) will be eligible for randomization.
- •Written Informed consent
排除标准
- •Signs or symptoms of breast cancer at enrolment;
- •Previous diagnosis of ductal carcinoma in situ or invasive breast cancer;
- •BRCA or p53 mutation carrier status;
- •General contraindications to MRI (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent;
- •Contraindications to any intravenous administration of contrast agent;
- •Ongoing or planned pregnancy (for the duration of the study);
- •Hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years
- •Presence of breast implants;
- •Previous diagnosis of cancer at any site;
- •Life-threatening diseases;
- •Mental disability precluding informed consent to participate
研究组 & 干预措施
Magnetic Resonance Imaging (MRI)
Patients will undergo MRI yearly
干预措施: Magnetic Resonance Imaging (MRI) (Other)
Mammography (Mx) + ultrasonography (US)
Patients will undergo yearly two-view (Mx) and breast US
干预措施: Mammography (Mx) + ultrasonography (US) (Other)
结局指标
主要结局
Rate of in situ and invasive breast cancers detected in the two arms of the study
时间窗: 36 months
The performance of MRI will be evaluated , in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer
次要结局
- Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms(3 years)
- Number of invasive diagnostic procedures in the two study arms.(3 years)
- Number of interval cancers in the two study arms.(3 years)
- Number of cancers (in situ and invasive) detected in excess in the experimental arm compared to the conventional arm (overdiagnosis) after 10 years of follow up(10 years)
- Proportion of the different histological characteristics of cancers detected in the two arms(3 years)
- Rate of eligible women who accept to enter the study.(3 years)
- Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study(3 years)
- Compliance to the intervention in the two study arms.(3 years)
研究者
Prof. Paolo Bruzzi
MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy