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临床试验/NCT03857152
NCT03857152Unknown不适用

Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications

The Leeds Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年12月3日最近更新:
适应症
干预措施

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

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

Other

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

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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