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NCT05767424
Prospective Observational Study for Breast Microcalcifications' Classification With Artificial Intelligence Techniques
Conditions: Breast Cancer, Microcalcification
Sex: Female
Ages: 18 Years – 88 Years
Healthy volunteers: No
Enrollment: 1426
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Location: Istituti Clinici Scientifici Maugeri SpA Pavia Lombardy
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
Eligibility Criteria
Inclusion Criteria:
* Female subjects;
* Age between 18 and 88 years;
* Detection of microcalcifications on clinical and screening mammography with or without indication for histological assessment by biopsy;
* Subjects who agree to participate in the study by signing and dating the Informed Consent form
Exclusion Criteria:
* Personal history of breast cancer
Source: ClinicalTrials.gov (NCT05767424). StuddyBuddy aggregates publicly available trial information.