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临床试验/NCT05450016
NCT05450016招募中不适用

Assessment of the Breast Cosmesis Using Deep Neural Networks: an Exploratory Study (ABCD)

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
720
试验地点
1
主要终点
Proportion of patients with excellent/good cosmesis

研究概览

简要总结

Surgery and radiotherapy in breast cancer patients can cause treatment changes and may affect the final breast appearance. In this study, we are trying to evaluate the post treatment breast photographs of the patients and subject these to Artificial Intelligence based program so as to classify into appropriate categories based upon changes from baseline. This automated solution will help in decreasing the time required to achieve this task by physicians in the clinic.

详细描述

A new algorithm was introduced which is based on deep neural network (DNN) which receives an image as input and returns the coordinates of the breast key points as output. These key points are then given to a shortest-path algorithm that models images as graphs to refine breast key point localization. The algorithm learns, directly from the image, to compute features and to use those features in the analysis of the aesthetic result. This comprises of two main modules: regression and refinement of heatmaps, and regression of key points. To perform the heatmap regression, the U-Net model is used.

The goal of the first module is to generate an intermediate representation consisting on a fuzzy localization for the key points that are to be detected.

The second module receives and refines this fuzzy localization, and through complex calculations, outputting the x and y coordinates of the keypoints, and the data generated from which can be used for disease / image classification.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Confirmed diagnosis of primary breast cancer (invasive or in situ)
  • Patient undergone breast conservation / Whole breast reconstruction
  • Patient received breast RT
  • Already provided written informed consent on earlier projects
  • Patient provided photographs of both breasts
  • Non-metastatic disease or oligometastatic
  • Age > 18 years
  • Reconsent given

排除标准

  • Mastectomy without whole breast reconstruction
  • Bilateral breast cancer
  • Partial breast irradiation
  • Male patient
  • Limited life expectancy due to co-morbidity
  • Patients undergoing brachy boost

结局指标

主要结局

Proportion of patients with excellent/good cosmesis

时间窗: 3 years

The patient photographs will be processed for artificial intelligence based analysis of prediction of breast cosmesis

次要结局

  • Kappa statistic between different deep neural networks(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tabassum Wadasadawala

Professor Tabassum Wadasadawala

Tata Memorial Centre

研究点 (1)

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