Study on Female Patients' Mammographic Texture Features (COMPRESS)

June 17, 2024 updated by: Tampere University Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participant diagnosed with breast cancer
Participants diagnosed with breast cancer who will undergo a mastectomy operation
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.
Experimental: Participant not diagnosed with breast cancer
Participants who will undergo a mastectomy operation for a non-breast cancer related clinical indication
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mammographic texture features
Time Frame: Through study completion, an average of 5 year
Aim: to evaluate how imaging parameters affect the mammographic texture features
Through study completion, an average of 5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 17, 2024

Primary Completion (Estimated)

December 15, 2035

Study Completion (Estimated)

December 15, 2038

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • R23077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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