Recruiting

Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

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.

ClinicalTrials.gov IDNCT06171607
PhasePHASE1
Enrollment100
SponsorUniversity of Southern California
Age18 Years
SexFEMALE
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Conditions studied

Breast Carcinoma

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.