A Cohort Study on feMale Patients' mammogRaphic texturE featureS: the COMPRESS Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mammographic texture features
研究概览
简要总结
Mammography is the most common method for breast imaging, and it provides information for model building and analysis. Radiomics applied to mammography has the potential to revolutionize clinical decision-making by providing valuable insights into risk assessment and disease detection. Despite this, the influence of imaging parameters and clinical and biological factors on radiological texture features remains poorly understood. There is a pressing need to overcome the obstacle of system-inherent effects on mammographic images to facilitate the translation of radiological texture features into routine clinical practice by enabling reliable and robust AI-based or AI-aided decision-making. Furthermore, understanding the relationship between imaging parameters, textural features, and clinical and biological information supports the clinical use of AI. The objective of this study is to evaluate AI methods for clinical practice and to study how it relates to clinical factors and biological features.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Candidate is a biological female aged 18 years or above;
- •Candidate is willing and able to give informed consent and gives their written consent for the participation in the study;
- •There is a clinical indication for a uni- or bilateral mastectomy
排除标准
- •Candidate lacks the capacity to provide informed consent;
- •Candidate has breast implants
研究组 & 干预措施
Participant not diagnosed with breast cancer
Participants who will undergo a mastectomy operation for a non-breast cancer related clinical indication
干预措施: AI tool (Device)
Participant diagnosed with breast cancer
Participants diagnosed with breast cancer who will undergo a mastectomy operation
干预措施: AI tool (Device)
结局指标
主要结局
Mammographic texture features
时间窗: Through study completion, an average of 5 year
Aim: to evaluate how imaging parameters affect the mammographic texture features
次要结局
- Biological features(through study completion, an average of 10 year)