MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Fractional perfusion (f)
研究概览
简要总结
This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).
The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.
详细描述
The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.
The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •[Cohort A] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
- •[Cohort B] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy
排除标准
- •for Both Cohorts:
- •Patients with prior history of breast cancer in the ipsilateral breast
- •Patients with a newly diagnosed breast cancer in the contralateral breast
- •Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR<60, contrast allergy, incompatible metal)
- •Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
- •Women who are pregnant
研究组 & 干预措施
Cohort A
Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing.
干预措施: Breast MRI (Diagnostic Test)
Cohort A
Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing.
干预措施: Laboratory Biomarker Analysis (Other)
Cohort B
Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing.
干预措施: Breast MRI (Diagnostic Test)
Cohort B
Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Fractional perfusion (f)
时间窗: 3.5 years
Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
Tissue diffusion (Dt)
时间窗: 3.5 years
Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
Transfer constant (Ktrans)
时间窗: 3.5 years
Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
次要结局
- Signal enhancement ratio (SER)(3.5 years)
- Transfer constant (Ktrans)(3.5 years)
- Oncotype DCIS Score(3.5 years)
- Fractional perfusion (f)(3.5 years)
- Apparent diffusion coefficient (ADC)(3.5 years)