Study on Female Patients' Mammographic Texture Features

NCT ID: NCT06469606

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2038-12-15

Brief Summary

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.

Conditions

Breast Cancer; Artificial Intelligence; Mammography

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Participant diagnosed with breast cancer

Participants diagnosed with breast cancer who will undergo a mastectomy operation

Group Type: EXPERIMENTAL

AI tool

Intervention Type: DEVICE

Both the arms will undergo the use of "AI tool" developed in the group. The tool will be trained to detect outcomes.

Participant not diagnosed with breast cancer

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

Group Type: EXPERIMENTAL

AI tool

Intervention Type: DEVICE

Both the arms will undergo the use of "AI tool" developed in the group. The tool will be trained to detect outcomes.

Interventions

AI tool

Both the arms will undergo the use of "AI tool" developed in the group. The tool will be trained to detect outcomes.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: collaborator

University of Oulu

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Otso Arponen, MD, PhD

Role: CONTACT

otso.arponen@tuni.fi

+3583311611

Other Identifiers

R23077

Identifier Type: -

Identifier Source: org_study_id