Clinical Evaluation of Contrast Enhanced Breast CT to Improve Staging and Treatment Follow up in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 413
- 主要终点
- Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.
研究概览
简要总结
Contrast-enhanced breast CT is a novel high resolution and fully 3D imaging method to document abnormalities within the breast. I will establish its value for breast cancer staging and in monitoring therapy response.
详细描述
Breast CT is a novel modality that has not been largely evaluated in a clinical setting. Only recently FDA and CE marked BCT machines have been released, and the number of installed bases internationally is below 10 (although rapidly rising).
Internationally only a few studies on contrast enhanced breast CT have been performed in small numbers of patients, albeit with excellent results. Nevertheless, substantial evidence for this novel modality is still absent. In particular, the correlation of enhancement and histological grade of DCIS, correlation of CEBCT findings with histopathology, and prediction and assessment of primary systemic treatment are open fields for which more substantial evaluation is clearly needed. In this study we want to establish the value of CEBCT in staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS), and in the evaluation of women treated with primary systemic therapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnoses of breast cancer
- •Scheduled for a pre-surgery staging contrast enhanced breast MRI
- •Eligible for primary systemic therapy
排除标准
- •Women with suspected or confirmed pregnancy
- •Women with prior history of breast cancer
- •Women who are breastfeeding
- •Women who are very frail and unable to cooperate
- •Women who cannot give informed consent
- •Contra indication of iodine contrast (i.e. untreatable contrast allergy, renal function impairment (GFR <60 ml/min/1.73m2))
- •Contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer)
- •Male subjects
结局指标
主要结局
Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.
时间窗: 3 years
Non-inferiority of CEBCT error rate against the golden standard, i.e. histopathology, to DCE MRI error rate against the golden standard for tumor staging. i.e. histopathology, to DCE MRI error rate against the golden standard for tumor staging.
Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI.
时间窗: 3 years
Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) (or AUROC).
次要结局
- Concordance of tumor extent between CEBCT and large section histopathology(3 years)
- Frequency of detection of contralateral cancers with CEBCT(3 years)
- Concordance between morphological and enhancement characteristics of cancers on CEBCT to their expected response to primary systemic therapy.(3 years)
- Potential of CEBCT predicting the response to primary systemic therapy early in treatment(3 years)