Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06171607
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Contrast-Enhanced Ultrasound — PROCEDURE
    Undergo CEUS
  • Perflutren Lipid Microspheres — DRUG
    Given IV
  • Sulfur Hexafluoride Lipid Microspheres — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 5, 2020
Status verified
Jan 2026
Primary completion
Nov 5, 2026
Completion
Nov 5, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (contrast agent, CEUS)
    Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.

Primary Outcome Measure

Radiomics-based ML-classifier framework [ Time Frame: Up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033
Janet Jaime
323-865-3205
Bino A. Varghese, PhD (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Janet Jaime
323-865-3205
Bino A. Varghese, PhD (PRINCIPAL_INVESTIGATOR)

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