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

NCT05767424 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1426

Last updated 2025-08-27

No results posted yet for this 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

Conditions

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2025-07-25
Completion
2028-07-25

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767424 on ClinicalTrials.gov