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NCT Number: NCT06469606

Study on Female Patients' Mammographic Texture Features

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mammographic texture features

    Time frame: Through study completion, an average of 5 year

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

Secondary outcomes

  1. Biological features

    Time frame: through study completion, an average of 10 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Otso Arponen, MD, PhD

CONTACT

[email protected]

+3583311611

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Kuopio University Hospital
  • Tampere University
  • University of Eastern Finland
  • University of Oulu
  • University of Turku

Registry information

Official study title

A Cohort Study on feMale Patients' mammogRaphic texturE featureS: the COMPRESS Trial

Acronym: COMPRESS

Important dates

Study start
2024
Primary completion
2035
Study completion
2038
First posted
Jun 21, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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