Using contrast enhanced ultrasound to identify breast masses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Janet.jaime@med.usc.edu
• Phone: 323-865-3205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.