Study on Female Patients' Mammographic Texture Features

Breast Cancer Clinical Trial

— COMPRESS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469606
• Other study ID #: R23077
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: December 15, 2038

Study information

• Verified date: June 2024
• Source: Tampere University Hospital
• Contact: Otso Arponen, MD, PhD
• Phone: +3583311611
• Email: otso.arponen[@]tuni.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 15, 2038
• Est. primary completion date: December 15, 2035
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Breast Cancer
• Mammography

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Tampere University Hospital	Kuopio University Hospital, Tampere University, University of Eastern Finland, University of Oulu, University of Turku

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammographic texture features	Aim: to evaluate how imaging parameters affect the mammographic texture features	Through study completion, an average of 5 year
Secondary	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)	through study completion, an average of 10 year