Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Carcinoma

Breast Neoplasms

Congenital Abnormalities

Calcinosis

Breast Diseases

Skin Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.

Ultrasound

MicoPure ultrasound

Undergo breast biopsy or surgical resection

Biopsy of Breast

Flemming Forsberg, PhD

This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

PRIMARY OBJECTIVES:

I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.

SECONDARY OBJECTIVES:

I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).

II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.

III. Estimate the improvements in patient care that may be achievable if MicroPure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.

Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality

Breast Microcalcifications Identified With MicroPure as a Marker for Malignancy Compared to Grayscale Ultrasound and Mammography (Using Biopsy as the Reference Standard)

The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.

The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.

The results of the three imaging methods will be compared to the pathology findings using the American College of Radiology Breast Imaging Reporting and Data System lexicon for the assessment of breast lesions.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Fabio Corsi, Professor

Sara Albasini, MsC

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

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

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

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

Identification of the typical characteristics extracted from the Artificial Intelligence systems

Evaluation of the diagnostic performance of a model that combines radiological characteristics and characteristics deriving from Raman spectroscopic analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality	NCT03031561	Breast Carcinom... Microcalcificat...	Ultrasound MicoPure ultras... Biopsy of Breas...	18 Years -	Thomas Jefferson University
Prospective Observational Study for Breast Microcalcifications' Classification With Artificial Intelligence Techniques	NCT05767424	Breast Cancer Microcalcificat...		18 Years - 88 Years	Istituti Clinici Scientifici Maugeri SpA
Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality	NCT03031561	Breast Carcinom... Microcalcificat...	Ultrasound MicoPure ultras... Biopsy of Breas...	18 Years -	Thomas Jefferson University

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