Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

University of Southern California

Status and phase

Enrolling

Phase 1

Conditions

Breast Carcinoma

Treatments

Procedure: Contrast-Enhanced Ultrasound

Drug: Perflutren Lipid Microspheres

Drug: Sulfur Hexafluoride Lipid Microspheres

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06171607

1B-19-5 (Other Identifier)

NCI-2022-03665 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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