Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

NCT06171607 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 1B-19-5NCI-2022-03665P30CA014089
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Radiomics-based ML-classifier framework

  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.

  Up to 12 months

• Performance of radiomics-based ML approach to prevent unnecessary biopsies

  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.

  Up to 12 months

Study Arms (1)

Diagnostic (contrast agent, CEUS)

EXPERIMENTAL

Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.

Procedure: Contrast-Enhanced Ultrasound; Drug: Perflutren Lipid Microspheres; Drug: Sulfur Hexafluoride Lipid Microspheres

Interventions

Perflutren Lipid Microspheres DRUG

Given IV

Also known as: Definity

Diagnostic (contrast agent, CEUS)

Sulfur Hexafluoride Lipid Microspheres DRUG

Given IV

Also known as: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres

Diagnostic (contrast agent, CEUS)

Contrast-Enhanced Ultrasound PROCEDURE

Undergo CEUS

Also known as: CEUS

Diagnostic (contrast agent, CEUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Southern California: lead

Study Sites (2)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bino A Varghese, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Jaime

CONTACT

323-865-3205; Janet.jaime@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: December 14, 2023
• Study Start: November 5, 2020
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 5, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (2)