Recruiting
Phase 1

Contrast Enhanced Ultrasound

Sponsor:

University of Southern California

Code:

NCT06171607

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Contrast-Enhanced Ultrasound

Perflutren Lipid Microspheres

Sulfur Hexafluoride Lipid Microspheres

Study Details

Brief 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.

Conditions

Breast Carcinoma

Study ID

NCT06171607

Start date

Nov 5, 2020

Status verified date

Jan, 2026

Completion date

Nov 5, 2027

Anticipated

Primary completion date

Nov 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (contrast agent, CEUS)

Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.

Interventions

Contrast-Enhanced Ultrasound

Undergo CEUS

Perflutren Lipid Microspheres

Given IV

Sulfur Hexafluoride Lipid Microspheres

Given IV

Primary outcome measure

  • Radiomics-based ML-classifier framework [ Time Frame: Up to 12 months ]
  • Performance of radiomics-based ML approach to prevent unnecessary biopsies [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Janet Jaime

323-865-3205Janet.jaime@med.usc.edu

Locations

Los Angeles County-USC Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Janet Jaime

323-865-3205Janet.Jaime@med.usc.edu

Principal Investigator:

Bino A. Varghese, PhD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Janet Jaime

323-865-3205Janet.Jaime@med.usc.edu

Principal Investigator:

Bino A. Varghese, PhD

More Information

Sponsor

University of Southern California

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-02-02.