RecruitingPhase 1NCT06171607

Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

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

Sponsor

University of Southern California

Enrollment

100 participants

Start Date

Nov 5, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Carcinoma

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

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 Criteria13

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