NCT00072501已完成不适用
Screening Breast Ultrasound in High-Risk Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 40
研究概览
简要总结
RATIONALE: Screening tests such as ultrasound and mammography may help doctors detect cancer cells early and plan more effective treatment for breast cancer. It is not yet known whether ultrasound is more effective than mammography in detecting breast cancer.
PURPOSE: This clinical trial is studying breast ultrasound to see how well it works compared to mammography in detecting cancer in women who are at high risk for breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the diagnostic yield of whole breast bilateral screening ultrasound and mammography for the detection of breast cancer in women at high risk for breast cancer.
- Determine the cancer detection yield of a single contrast-enhanced magnetic resonance imaging (MRI) examination after 3 rounds of annual screening with ultrasound and mammography in these participants. (MRI component of the study)
Secondary
- Determine the independent sensitivity and specificity of these screening methods in these participants.
- Correlate performance of these screening methods with selected participant characteristics (e.g., breast density and heterogeneity of the parenchyma).
- Validate the sonographic classification of lesions as "probably benign" and estimate the rate of malignancy in participants screened with these methods.
- Determine the cost effectiveness associated with screening breast ultrasound, in terms of radiologist and resource time performing the exam and the induced cost of screening ultrasound (e.g., follow-up and biopsy).
- Determine the reproducibility of lesion identification, measurement of lesion diameters, and volume and recording of lesion location on ultrasound in these participants.
- Determine the size, type, grade, and nodal status of cancers seen only on MRI in these participants. (MRI component of the study)
- Estimate the rate of benign biopsies and short interval follow-up induced only by MRI in these participants. (MRI component of the study)
- Determine the cost effectiveness of MRI, including induced costs of unnecessary biopsies and follow-up. (MRI component of the study)
- Compare the agreement among multiple examiners in sonographic, mammographic, and MRI feature analysis (using terms from the BI-RADS® lexicon) and final assessment (e.g., estimated probability of malignancy and/or recommendation for biopsy) in the enriched set of diagnostic training cases with consensus and histopathologic reference standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Screening
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •At high risk for breast cancer, as defined by at least 1 of the following:
- •Known BRCA1 or BRCA2 mutation
- •Personal history of breast cancer with conserved breast analyzed separately
- •Prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, or atypical papilloma and not receiving chemoprevention (i.e., not on tamoxifen, raloxifene, anastrazole, or any other aromatase inhibitor) OR any of these atypical lesions (including phyllodes tumors) AND first-degree relative diagnosed with breast cancer under age 50
- •Prior biopsy showing lobular carcinoma in situ
- •Age 30 and under and received prior chest and/or mediastinal and/or axillary irradiation ≥ 8 years ago
- •Risk of breast cancer meeting one of the following criteria:
- •Gail or Claus lifetime cancer risk ≥ 25%
- •Gail 5-year cancer risk ≥ 2.5%
- •Gail 5-year cancer risk ≥ 1.7% AND known to have extremely dense breasts (≥ 75% dense) by most recent mammogram
- •Heterogeneously dense (≥ 50% dense) or extremely dense (≥ 75% dense throughout the entire breast) breast parenchyma in at least 1 breast by mammogram* OR unknown breast density due to no prior mammogram NOTE: *No fatty breasts or minimal scattered fibroglandular density
- •Most recent mammogram* (if any) was interpreted as negative, benign, and/or remarkable only for post-treatment changes NOTE: *At least 11 full months since prior mammogram
- •No current signs or symptoms of breast cancer (e.g., palpable breast masses, bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast[s] or nipple[s])
- •History of breast cancer allowed provided ≥ 1 year has elapsed since the last treatment with surgery and there is no known distant metastases and no known residual tumor
- •No bilateral breast implants
- •Participants with a unilateral breast implant who would otherwise be eligible for study participation allowed (only breast without implant is evaluated)
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •25 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Glomerular filtration rate ≥ 30 mL/min
- •Not pregnant or nursing
- •Fertile participants must use effective contraception
- •Able to undergo adequate mammography and cooperate with breast ultrasound
- •No concurrent medical or psychiatric condition that would preclude biopsy
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No contraindications to MRI (e.g., pacemaker, aneurysm clip, or other implanted magnetic device)*
- •No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative*
- •Must have intravenous access*
- •Weight < 300 pounds*
- •Physically able to tolerate positioning in the MRI scanner*
- •Able to undergo contrast-enhanced MRI within 4 weeks after completing both study ultrasound and mammogram at 24-month time point*
- •Agrees to undergo follow-up MRI at 6 months and/or MRI-guided vacuum-assisted biopsy or ultrasound-guided core biopsy (if needed)* NOTE: *MRI component of the study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No concurrent chemotherapy (MRI component of the study)
- •Endocrine therapy
- •See Disease Characteristics
- 另有 16 项未显示
排除标准
- 未提供
研究者
研究点 (40)
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