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ACTIVE NOT RECRUITING
NCT05767424

Prospective Observational Study for Breast Microcalcifications' Classification With Artificial Intelligence Techniques

Sponsor: Istituti Clinici Scientifici Maugeri SpA

View on ClinicalTrials.gov

Summary

Breast microcalcifications are a common mammographic finding. Microcalcifications are considered suspicious signs of breast cancer and a breast biopsy is required, however, cancer is diagnosed in only a few patients. Reducing unnecessary biopsies and rapid characterization of breast microcalcifications are unmet clinical needs. This study intends to implement a classification method for breast microcalcifications (as begnin or malign) with Artificial Intelligence techniques on mammographic images, evaluating the diagnostic performance (accuracy) of this approach. Another aim is the development of a diagnostic tool able to determining in-situ the biomolecular characteristics of microcalcifications. Raman spectroscopy (RS) is a highly specific method from the biomolecular point of view and it is able to explore molecular composition of a given sample through its direct irradiation (through laser light) and the simultaneous acquisition of emission signals. RS information could be combined togheter with imaging features to implement an AI model for the combined classification of breast microcalcifications

Key Details

Gender

FEMALE

Age Range

18 Years - 88 Years

Study Type

OBSERVATIONAL

Enrollment

1426

Start Date

2022-07-22

Completion Date

2028-07-25

Last Updated

2025-08-27

Healthy Volunteers

No

Locations (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy