Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- BI-RADS score
研究概览
简要总结
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
- •Tumors > 5 cm (= T3) or
- •Tumors with invasion of the skin or chest wall (= T4) or
- •Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
- •Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
排除标准
- •History of allergic reactions to iodinated contrast agents
- •Pregnancy or breast feeding
- •Treatment of thyroid disease with radioactive iodine
- •Use of metformin
- •Creatinine clearance < 45 ml/min
- •Chronic or acutely worsening renal disease
- •Patients who are declared incompetent
结局指标
主要结局
BI-RADS score
时间窗: On the same 1 day as the regular PET-CT scan was performed
BI-RADS score according to the ACR BI-RADS lexicon
Visual tumor conspicuity
时间窗: On the same 1 day as the regular PET-CT scan was performed
The conspicuity of tumors will be graded on a 4-point confidence scale
次要结局
- Iodine content(On the same 1 day as the regular PET-CT scan was performed)
- Iodine enhancement(On the same 1 day as the regular PET-CT scan was performed)