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临床试验/NCT04468867
NCT04468867Unknown不适用

Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy

The Leeds Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Tumour size

研究概览

简要总结

Some women who have been diagnosed with a breast cancer will require chemotherapy as part of their treatment. The chemotherapy can be given before breast surgery - neoadjuvant chemotherapy or after breast surgery - adjuvant chemotherapy. Whether chemotherapy is given before or after does not affect the clinical outcomes for the woman - ie there is no disadvantage to the woman. Due to the fact that giving chemotherapy before has no disadvantages, many of the oncologists like to give the chemotherapy before because they can see if the breast cancer is responding. They are able to do this by using imaging. The best imaging test is breast MRI. Ultrasound can be used but studies have shown that it is not as good. However, whole breast ultrasound (ABUS) provides 3 dimensional information similar to breast MRI and the purpose of our study is to see if ABUS performs similar to breast MRI in being able to see if a tumour is responding to the chemotherapy. The breast MRI requires women to lie facing down and takes about 20mins. It involves an injection of contrast called gadolinium via a cannula. ABUS involves scanning the whole breast with the patient lying on their back and takes 10mins. There is no injection of contrast. MRI is an expensive test and often there is limited access to the scanner and so patients may have to wait for an appointment. ABUS because it is an automated process for obtaining the images can be performed in the breast unit in a timely manner without the issue of competing demands. All women who agree to take part in the study will have both the breast MRI - standard or care and the ABUS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All female participants eligible for neoadjuvant chemotherapy and planning surgical treatment
  • Able to give informed consent

排除标准

  • All female particpants having neoadjuvant chemotherapy as palliative treatment with no surgery planned
  • Unable to provide informed consent
  • Unable to have breast MRI scan due to clautrophobia or allergy to gadolineum

结局指标

主要结局

Tumour size

时间窗: 20 mins

Response will be assessed using RECIST criteria. Longest diameter response was scored based on the RECIST guidelines (PD\>20% increase, SD\<20% increase to\<30% decrease, PR\>30% decrease in longest diameter and CR if no tumour is visible).

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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