Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms

Breast Cancer Clinical Trial

— ALGO-MAMMO  

Official title:

Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640011
• Other study ID #: 7964
• Status: Completed
• Start date: April 20, 2021
• Est. completion date: May 20, 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
France	Service de Radiologie 1 - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This assessment is based on contouring the tumor area on mammograms.	Files analysed retrospectively from January 01, 2010 to January 01, 2020 will be examined