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Clinical Trials in Italy / NCT05767424
Active, not recruiting Observational

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

NCT05767424 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Phase
Observational
Started
2022-07-22
Last updated
2026-08-26

Condition(s) studied

Breast CancerMicrocalcification

Study 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

Sex
FEMALE
Min age
18 Years
Max age
88 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istituti Clinici Scientifici Maugeri SpA Pavia Lombardy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05767424 on ClinicalTrials.gov ↗ ← All trials in Italy