Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of benign biopsies
研究概览
简要总结
Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Therefore, 90% of women will be subjected to a biopsy. 25-30% of the biopsies will show cancer. Contrast enhanced spectral mammography (CESM) is where contrast is given and then a mammogram performed. The theory is that high risk DCIS and invasive cancers have an increased blood supply and will therefore enhance more than benign lesions within the breast. If CESM can identify calcifications that are cancerous then we maybe able to reduce the number of women who have benign biopsies. This is patient focused as women would not require a biopsy and be able to be reassured at the same visit. This is also a cost-saving for the Trust by reducing unnecessary biopsies. This also supports the findings of the Marmot review by aiming to reduce harm by over-diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Recalled for second stage screening due to microcalcifications on the mammogram
- •Renal function is within normal limits
- •No known allergies to contrast
- •Able to give informed consent
排除标准
- •Known allergy to contrast
- •Renal impairment
- •Unable to provide informed consent
- •Having radioactive iodine treatment for hyperthyroidism
研究组 & 干预措施
Patient receiving CESM
Patients will receive CESM in addition to normal standard treatment.
干预措施: Contrast enhanced spectral mammography (CESM) (Diagnostic Test)
结局指标
主要结局
Number of benign biopsies
时间窗: 3 years
Total number of benign biopsies identified whilst undergoing CESM.
次要结局
未报告次要终点
