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临床试验/NCT05796219
NCT05796219已完成不适用

Technical Development of Automated Low Dose Risk Assessment Mammography (ALDRAM) in Women Attending for Annual Mammography Through a Family History Clinic

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2019年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Correlation between full dose and low dose percent mammographic density estimates

研究概览

简要总结

Breast cancer (BC) is the commonest cause of death in young women. Breast screening in women aged 35-45, at increased risk due to their family history, has been shown to improve survival. However, 80% of women who develop BC do not have a family history. Numerous studies have shown that high mammographic density (MD) is one of the strongest risk factors for BC development. Full field digital mammography (FFDM) can be used to assess MD, however it is not recommended for population BC screening in those <40 years of age due to the concerns about the use of ionising radiation. Safe and accurate high throughput methods to quantify MD in young women are thus required to improve risk prediction and reduce BC mortality. This study aims to develop a low dose mammogram, with quantification of density using artificial intelligence, to facilitate high throughput risk assessment in young women. 600 women aged 30-45, previously identified as being at increased risk of BC and attending for annual mammography at The Nightingale Centre will be recruited. Participants will undergo FFDM of the right breast as usual, however, following acquisition of the craniocaudal (CC) view, the breast will remain compressed and the mammogram dose reduced by 90% to deliver a LD mammogram. This process will be repeated for the right medio-lateral oblique (MLO) view. The left breast FFDM will proceed as normal. It is estimated that each extra exposure will take 1-2 minutes only. Deep machine learning methods will be used to define the relationship between standard FFDM views and their low dose counterparts and determine which view (CC vs MLO) provides the best correlation to be taken forward to the next stage of the research.

详细描述

The more prolonged compression of the breast required to acquire the LD images may cause some additional breast discomfort. However, in a similar study in The Netherlands only 1% of women could not tolerate the procedure.

Participants will receive an extra dose of ionising radiation amounting to 20% of the radiation dose of a single FFDM view (of which 4 are usually taken, 2 on each breast). The risks associated with this are described in section B and entered into the PIS.

The research question for this study is whether an automated, low dose mammogram can be developed to provide an accurate assessment of mammographic density, and thus breast cancer risk, in women aged 30-45.

The two key objectives are:

  1. To develop machine learning methods for automated quantification of mammographic density using low dose mammograms in a study of 600 women attending for annual Full Field Digital Mammography (FFDM).
  2. To validate Automated Low Dose Risk Assessment Mammography (ALDRAM) against automated FFDM assessment that has been shown to predict BC risk.

研究设计

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

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Females with moderate to high risk of breast cancer, identified through and attending for annual review and mammography at the family history clinic, Nightingale Centre, Manchester
  • •Current age 30-45 years
  • •Capable of providing informed consent to a patient information sheet written in English

排除标准

  • •Prior breast cancer
  • •Prior breast augmentation or reduction
  • •Participation in the TARA-Prev study which included an additional mammogram and thus radiation dose

研究组 & 干预措施

Low dose mammogram

Other

Low dose mammo to compare with standard mammo

干预措施: Low dose mammogram (Radiation)

结局指标

主要结局

Correlation between full dose and low dose percent mammographic density estimates

时间窗: The low dose mammogram will be taken immediately after the full dose exposure, under the same breast compression.

Full dose and Low dose mammograms will be analysed using an established AI technique, the predicted Visual Analogue Score (pVAS), to determine the percent mammographic density (%MD). Correlation between the full and low dose image derived %MD across the whole study population will be assessed using Pearson correlation coefficient.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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