Study on Female Patients' Mammographic Texture Features

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTampere University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Candidate lacks the capacity to provide informed consent;

Candidate has breast implants

Trial design

Design model

Single group

Treatments tested in this trial

  • AI tool

    Device

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Participant diagnosed with breast cancerExperimental treatment 1 intervention
Group B: Participant not diagnosed with breast cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mammographic texture features

Aim: to evaluate how imaging parameters affect the mammographic texture features

Time frame
Through study completion, an average of 5 year

Secondary outcomes

1

Biological features

Aim: To evaluate whether there is an interplay between mammographic texture feature parameters and pathological and biological features (e.g., breast cancer biomarkers)

Time frame
through study completion, an average of 10 year

Other outcomes

Sponsors and contacts

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Tampere University Hospital

Lead sponsor

Tampere University

Collaborator

Kuopio University Hospital

Collaborator

University of Eastern Finland

Collaborator

University of Turku

Collaborator

University of Oulu

Collaborator