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OpenTrials
Completed

NCT Number: NCT05640011

Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms

This aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative French population (from several hospital centers and liberals from several departments in the west and east of France).

This population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. The control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers).

This innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of "difficult" files.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Service de Radiologie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult woman (40 to 75 years old)
  • Treatment at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer
  • including mammography and histological evidence available
  • Patient who has already given her consent for the reuse of her anonymous data for research purposes

Exclusion criteria

  • Woman who expressed her opposition to participating in the study

Treatment and study plan

Primary outcomes

  1. Evaluate the diagnostic performance (sensitivity, specificity) for operator tumor detection assisted by mammographic diagnostic aid software, and compare it to the diagnostic performance of an unassisted operator.

    Time frame: Files analysed retrospectively from January 01, 2010 to January 01, 2020 will be examined

    This assessment is based on contouring the tumor area on mammograms.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ALGO-MAMMO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Nov 8, 2023

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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