Prospective Observational Study for Breast Microcalcifications' Classification With Artificial Intelligence Techniques
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Breast microcalcifications are currently classified using the BI-RADS radiological scale. In case of suspicious microcalcifications (B3), it is recommended to perform a biopsy assessment for histopathological evaluation. However, about 70-80% of performed biopsies shows benign histology that does not require surgical treatment. Core biopsies are invasive procedures with a biological, psychological (patient discomfort), organizational and economic (for the Health Care System) costs. Therefore, accuracy's improvement in radiological classification of microcalcifications is essential. Recently, various approaches have been reported in the literature to detect and classify microcalcification as benign or suspicious in digital mammograms. Analysis methods based on the use of deep learning (DL) have also emerged as promising for processing mammography images. Convolutional neural networks (CNNs) are currently the state of the art for image classification in many application fields in the field of computer vision. This study intends to implement a classification method for breast microcalcifications (as benign or malign) with Artificial Intelligence (AI) techniques on mammographic images, evaluating the diagnostic performance (accuracy) of this approach. The evaluation will be conducted with reference to the standard radiological approach (BI-RADS classification).
Together with the application of AI systems to mammographic imaging, a further current clinical need is the development of a diagnostic tool able to determining in-situ the biomolecular characteristics of microcalcifications, accurately discriminating their nature without take tissue, fixation and embedding of the sample in paraffin, and without highly specialized evaluation by the pathologist. Raman spectroscopy (RS) is a highly specific method from the biomolecular point of view and, at the same time, it is compatible with in-vivo measurements. It consists in a biophotonic approach 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
Study Design
Outcome Measures
Primary Outcome Measures
- Artificial Intellicence method for classification [36 months]
Classification method of breast microcalcifications with Artificial Intelligence techniques on mammography images
Secondary Outcome Measures
- Radiological features extraction [36 months]
Identification of the typical characteristics extracted from the Artificial Intelligence systems
- Artificial Intellicence method for combined classification [36 months]
Evaluation of the diagnostic performance of a model that combines radiological characteristics and characteristics deriving from Raman spectroscopic analysis
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituti Clinici Scientifici Maugeri SpA | Pavia | Lombardia | Italy | 27100 |
Sponsors and Collaborators
- Istituti Clinici Scientifici Maugeri SpA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2669