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

NCT05767424 | Active Not Recruiting

• 1 other identifier: 2669
• Study Type: observational
• Target: 1,426
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Microcalcification

Keywords

Breast microcalcification; Breast cancer; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Artificial Intellicence method for classification

  Classification method of breast microcalcifications with Artificial Intelligence techniques on mammography images

  36 months

Secondary Outcomes (2)

• Radiological features extraction

  36 months

• Artificial Intellicence method for combined classification

  36 months

Eligibility Criteria

• Age: 18 Years - 88 Years
• Gender Eligibility Details: Breast lesion is gender specif
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast patological patients who experience microcalcification lesion

You may qualify if:

• 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

You may not qualify if:

• Personal history of breast cancer

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Calcinosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: July 22, 2022
• Primary Completion: July 25, 2025
• Study Completion (Estimated): July 25, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-07

Locations

IT (1)