Using contrast enhanced ultrasound to identify breast masses

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

This study is testing if a special type of ultrasound with a contrast agent can help doctors tell the difference between harmless and harmful breast lumps to reduce unnecessary biopsies for patients with certain types of breast masses.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Southern California (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT06171607 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of contrast enhanced ultrasound (CEUS) in distinguishing between benign and malignant cystic breast masses. The study aims to develop a radiomics workflow and machine learning framework to analyze CEUS parameters and improve classification accuracy for breast malignancy. Patients will receive a contrast agent intravenously and undergo a CEUS scan, with the goal of potentially reducing unnecessary biopsies. The trial focuses on newly diagnosed breast masses categorized as BI-RADS 4a, 4b, 4c, or 5 by conventional ultrasound.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with newly diagnosed breast masses classified as BI-RADS 4a, 4b, 4c, or 5.

Not a fit: Patients with contraindications to microbubble contrast agents, pregnant or lactating women, and those currently undergoing neoadjuvant chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of breast masses, reducing the need for unnecessary biopsies.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques like CEUS for breast mass evaluation, indicating potential success for this approach.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 1 other locations

• Los Angeles County-USC Medical Center — Los Angeles, California, United States (Recruiting)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Bino A Varghese, PhD — University of Southern California
• Study coordinator: Janet Jaime

Conditions Breast Carcinoma