MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,007
- 试验地点
- 21
- 主要终点
- MRI Diagnostic Yield of Cancers in the Contralateral Breast
研究概览
简要总结
RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.
PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.
详细描述
OBJECTIVES:
- Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
- Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.
- Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).
OUTLINE: This is a multicenter study.
Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.
Patients are followed at 12-18 and 24-30 months.
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
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
- •Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
- •Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
- •Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
- •Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
- •No remote history of breast cancer
- •No new breast symptoms within the past 60 days for which further evaluation is recommended
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No pacemaker
- •No magnetic aneurysm clips
- •Not pregnant
- •No implanted magnetic device
- •No severe claustrophobia
- •No other contraindications to MRI
- •No psychiatric, psychological, or other condition that would preclude informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 6 months since prior anticancer chemotherapy
- •Endocrine therapy
- •No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
MRI Evaluation of Contralateral Breast
The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.
干预措施: MRI (Procedure)
结局指标
主要结局
MRI Diagnostic Yield of Cancers in the Contralateral Breast
时间窗: within 90 days of a negative mammogram of the study breast
To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam. the "Test" status was defined based on combinations of the following 4 factors: 1. The initial BI-RADs: from the MRI of the contralateral breast 2. The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4). 3. Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI 4. Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI
次要结局
- MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy(within 90 days of a negative mammogram of the study breast)
- AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast(within 90 days of a negative mammogram of the study breast)