Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

PRIMARY OBJECTIVES:

I. To examine and compare the distribution of CEUS parameters in breast masses that were evaluated as Breast Imaging Reporting and Data System (BI-RADS) 4a, 4b, 4c or 5 by conventional ultrasound (US) and were recommended for ultrasound guided biopsy, and to evaluate whether these parameters can be used to classify suspicious cystic-appearing breast masses as benign or malignant.

Ia. To develop a CEUS-based radiomics workflow to extract radiomic metrics (> 1600 features) in classifying breast mass malignancy (Radiomics).

Ib. To develop a systematic and rigorous machine learning (ML)-based framework comprised of classification, cross-validation and statistical analyses to identify the best performing classifier for breast malignancy stratification based on CEUS-derived radiomic metrics (time-intensity curve [TIC] analysis and Radiomics).

Ic. To assess the independent contribution of radiomics classifier and time-intensity curve classifier to the model accuracy in discriminating benign from malignant cases (TIC analysis versus [vs.] Radiomics).

Id. To assess the potential benefit of machine learning classifier in preventing unnecessary biopsy (TIC analysis and Radiomics).

OUTLINE:

Patients receive a contrast agent (Lumason or DEFINITY) intravenously (IV) and then undergo CEUS scan over 60-90 minutes.

Inclusion criteria

• Newly diagnosed breast masses assigned as BIRADS 4a, 4b, 4c or 5 by conventional US and recommended for ultrasound guided biopsy
• Age >= 18 years
• Female

Exclusion criteria

• Contraindications to microbubble contrast: Patients who have a known pulmonary hypertension and any known hypersensitivity to US contrast agent
• Women with renal failure or insufficiency (only if patient is receiving CESM scan)
• Women with Iodine contrast allergy (only if patient is receiving CESM scan)
• Women with the largest side of the mass measuring ≤ 1 cm (only if patient is receiving CEUS scan)
• Women who are pregnant, possibly pregnant, or lactating
• Women currently undergoing neoadjuvant chemotherapy
• Women < 18 years of age
• Patient ≤ 30 years (only if patient is receiving CESM scan)
• Masses in the same breast that had prior lumpectomy for cancer
• Women with cancer in the same breast will be excluded however, women with cancer in the contralateral breast will be eligible to participate in the study
• Women with an allergy to perflutren (only if patient is receiving CEUS scan)
• Prior history of biopsy for that specific lesion
• Women with breast implants