NCT06171607

Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 conventional ultrasound (US) and were recommended for ultrasound guided biopsy, and to evaluate whether these parameters can be used to classify suspicious cystic-appearing breast masses as benign or malignant. Ia. To develop a CEUS-based radiomics workflow to extract radiomic metrics (\> 1600 features) in classifying breast mass malignancy (Radiomics). Ib. To develop a systematic and rigorous machine learning (ML)-based framework comprised of classification, cross-validation and statistical analyses to identify the best performing classifier for breast malignancy stratification based on CEUS-derived radiomic metrics (time-intensity curve \[TIC\] analysis and Radiomics). Ic. To assess the independent contribution of radiomics classifier and time-intensity curve classifier to the model accuracy in discriminating benign from malignant cases (TIC analysis versus \[vs.\] Radiomics). Id. To assess the potential benefit of machine learning classifier in preventing unnecessary biopsy (TIC analysis and Radiomics). OUTLINE: Patients receive a contrast agent (Lumason or DEFINITY) intravenously (IV) and then undergo CEUS scan over 60-90 minutes.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Contrast-Enhanced Ultrasound	Undergo CEUS
DRUG	Perflutren Lipid Microspheres	Given IV
DRUG	Sulfur Hexafluoride Lipid Microspheres	Given IV

Timeline

• Start date: 2020-11-05
• Primary completion: 2026-11-05
• Completion: 2027-11-05
• First posted: 2023-12-14
• Last updated: 2026-02-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study