Status:
RECRUITING
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 wav...
Detailed Description
PRIMARY OBJECTIVES: I. To examine and compare the distribution of CEUS parameters in breast masses that were evaluated as Breast Imaging Reporting and Data System (BI-RADS) 4a, 4b, 4c or 5 by convent...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06171607
Start Date
November 5 2020
End Date
November 5 2027
Last Update
July 30 2025
Active Locations (2)
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1
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033