Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics

1B-19-5

This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant. Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). Ultrasounds are widely used to diagnose many diseases in the body. This trial may help researchers learn if using CEUS will help in determining whether or not an ultrasound guided biopsy is necessary.

2020-11-05

2024-11-05

2025-11-05

Recruiting

Early phase I

100

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 who are pregnant, possibly pregnant, or lactating * Women currently undergoing neoadjuvant chemotherapy * Women \< 18 years of age * 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 * Prior history of biopsy for that specific lesion

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-12-14