NCT06171607 · University of Southern California
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
What this study 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.
View original scientific description
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
PROCEDURE
Contrast-Enhanced Ultrasound
Undergo CEUS
DRUG
Perflutren Lipid Microspheres
Given IV
DRUG
Sulfur Hexafluoride Lipid Microspheres
Given IV
Primary outcome measures
Radiomics-based ML-classifier framework
Time frame: Up to 12 months
The performance of radiomics-based ML classifier framework will be compared to the performance of the TIC metrics. The joint performance of radiomics and TIC analysis will be compared to their individual performances. The classifier performance will be assessed using the area under curve (AUC). The Z-test will be used to compare the difference between the area under the curves 1) AUCboth versus (vs.) AUCradiomic 2) AUCboth vs. AUCTIC 3) AUCTIC vs. AUCradiomic.
Performance of radiomics-based ML approach to prevent unnecessary biopsies
Time frame: Up to 12 months
Will assess the percentage of benign cases that can be classified as benign by ML (Specificity) thus been prevented from biopsy. Will select the diagnostic cut-off point based on the ROC curve constructed from the predicted probability. Such a cut-off point will result in a maximal sensitivity (100%). Specificity with 95% Clopper Pearson confidence interval will be obtained.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
- Los Angeles, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations