Using artificial intelligence to classify breast microcalcifications
Prospective Observational Study for Breast Microcalcifications' Classification With Artificial Intelligence Techniques
This study is testing whether using artificial intelligence to analyze mammogram images can better identify breast microcalcifications and help reduce unnecessary biopsies for women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1426 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Pavia, Lombardia) |
| Trial ID | NCT05767424 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the classification of breast microcalcifications, which are often indicative of breast cancer, by utilizing artificial intelligence techniques on mammographic images. The study will evaluate the accuracy of these AI methods compared to traditional BI-RADS classification, with the goal of reducing unnecessary biopsies that often yield benign results. Additionally, the study will explore the use of Raman spectroscopy to assess the biomolecular characteristics of microcalcifications in real-time. By enhancing diagnostic performance, this approach seeks to address significant clinical needs in breast cancer detection.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 18 to 88 who have detected microcalcifications on mammograms and may require a biopsy.
Not a fit: Patients with a personal history of breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the number of unnecessary breast biopsies and improve the accuracy of breast cancer diagnoses.
How similar studies have performed: Other studies utilizing AI for medical imaging have shown promising results, indicating that this approach may lead to significant advancements in diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Lombardia
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.