Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
Recruiting · NCT06171607 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Southern California
View the official record on ClinicalTrials.gov →Interventions studied
Contrast-Enhanced UltrasoundPerflutren Lipid MicrospheresSulfur Hexafluoride Lipid Microspheres
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 1 US state.
- Los Angeles County-USC Medical Center - Los Angeles, California, United States
- USC / Norris Comprehensive Cancer Center - Los Angeles, California, United States