Study on Female Patients' Mammographic Texture Features (COMPRESS)

Tampere University Hospital

Status: Not yet enrolling

Conditions: Breast Cancer; Artificial Intelligence; Mammography

Treatments: Device: AI tool

Study type: Interventional

Funder types: Other

Identifiers

NCT06469606

R23077

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Candidate lacks the capacity to provide informed consent;
• Candidate has breast implants

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Participant diagnosed with breast cancer

Experimental group

Description:

Participants diagnosed with breast cancer who will undergo a mastectomy operation

Treatment:

Device: AI tool

Participant not diagnosed with breast cancer

Experimental group

Description:

Participants who will undergo a mastectomy operation for a non-breast cancer related clinical indication

Treatment:

Device: AI tool