Contrast-Enhanced Ultrasound for Identifying Breast Masses
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byBino A Varghese, PhD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Southern California
Disqualifiers: Pulmonary hypertension, Pregnant, Neoadjuvant chemotherapy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing neoadjuvant chemotherapy, you cannot participate in the trial.
What data supports the effectiveness of the drug Perflutren Lipid Microspheres for identifying breast masses?
Research shows that microbubble contrast agents, like Perflutren Lipid Microspheres, enhance ultrasound imaging, which can help in distinguishing between benign and malignant breast lesions. This is supported by studies using similar agents, such as Sonazoid, which have shown improved diagnostic accuracy in breast cancer evaluation.
12345How does contrast-enhanced ultrasound differ from other treatments for identifying breast masses?
Contrast-enhanced ultrasound (CEUS) using Sonazoid (perflubutane) is unique because it enhances ultrasound images to help differentiate between benign and malignant breast lesions, offering a non-invasive alternative to traditional methods like MRI. This approach can provide real-time imaging and potentially predict the malignancy grade of breast cancer, which is not typically possible with standard ultrasound.
14678Eligibility Criteria
This trial is for individuals with breast masses that need to be checked if they're benign (not cancer) or malignant (cancer). It's not specified who can't join, but typically those with allergies to the contrast agents used or certain health conditions may be excluded.Inclusion Criteria
I am 18 years old or older.
My breast mass is suspicious and needs a biopsy.
I am female.
Exclusion Criteria
I am a woman currently receiving chemotherapy before surgery.
I am allergic to perflutren.
I am a woman under 18 years old.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Diagnostic Imaging
Patients receive a contrast agent intravenously and undergo CEUS scan over 60-90 minutes
1 day
1 visit (in-person)
Analysis
Development and assessment of radiomics-based ML classifier framework and TIC analysis
Up to 12 months
Follow-up
Participants are monitored for safety and effectiveness after diagnostic imaging
4 weeks
Participant Groups
The study is testing whether a special type of ultrasound called CEUS, using Sulfur Hexafluoride and Perflutren Lipid Microspheres as contrast agents, can help tell apart non-cancerous from cancerous breast lumps without needing a biopsy.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (contrast agent, CEUS)Experimental Treatment3 Interventions
Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Los Angeles County-USC Medical CenterLos Angeles, CA
USC / Norris Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Efficacy of sonazoid (perflubutane) for contrast-enhanced ultrasound in the differentiation of focal breast lesions: phase 3 multicenter clinical trial. [2016]The objective of our study was to compare the efficacy of contrast-enhanced ultrasound (CEUS) using the ultrasound contrast agent Sonazoid (perflubutane) with unenhanced ultrasound and supplementary contrast-enhanced MRI in the differential diagnosis (benign vs malignant) of focal breast lesions. The safety of Sonazoid was also assessed in this study.
Microbubble contrast agent for color Doppler US: effect on breast masses. Work in progress. [2016]To evaluate the effects of a new microbubble contrast agent for ultrasound (US) on breast masses.
Color-doppler using contrast medium in evaluating the response to neoadjuvant treatment in patients with locally advanced breast carcinoma. [2005]The aim of our study was to assess the color-Doppler ultrasound (CDU) pattern in the analysis of neoadjuvant preoperative treatment of patients with locally advanced breast carcinoma, improvement after injection of contrast medium (Levovist) and possible correlations between morphological and vascular aspects of the neoplasm and postoperative histopathological findings.
Evaluation of Malignancy Grade of Breast Cancer Using Perflubutane-Enhanced Ultrasonography. [2017]Whether the contrast effects of perflubutane on contrast-enhanced ultrasonography can predict the malignancy grade of breast cancer is unknown. We analyzed associations between perfusion parameters created from time-intensity curves based on enhancement intensity and temporal changes in contrast-enhanced ultrasonography and clinicopathologic factors in 100 consecutive patients with invasive breast cancer. Values of perfusion parameters were significantly greater in estrogen receptor-negative than -positive tumors (peak intensity, p = 0.0002; ascending slope, p = 0.006; area under the curve, p = 0.0006). Variations in the peak intensity of Ki-67 were significantly correlated in all tumors (r = 0.54, p
The use of a micro-bubble contrast agent to allow visualization of the biliary tree. [2016]Micro-bubble contrast agents have been used as contrast agents in the vascular system to allow visualization of blood flow by ultrasound. We examined the use of this type of contrast agent for visualization of bile duct by ultrasound. A laparotomy was performed on a domestic farm pig and the common bile duct was cannulated with a 20 gauge catheter. The contrast agent, perflutren lipid microspheres (Definity), was injected in different dilutions. Sonographic images were obtained by scanning directly on the pig liver. The use of the micro-bubble contrast in the biliary system provided excellent visualization of the bile duct down to ducts as small as fifth-order branches and demonstrated bile ducts
The Role of Contrast-Enhanced Ultrasound in the Diagnosis and Pathologic Response Prediction in Breast Cancer: A Meta-analysis and Systematic Review. [2021]To determine the overall performance of contrast-enhanced ultrasound (CEUS) in differentiating between benign and malignant breast lesions and in predicting the pathologic response to neoadjuvant chemotherapy (NAC) in patients with breast cancer (BC).
[Contrast enhanced power Doppler and color Doppler ultrasound in breast masses: Efficiency in diagnosis and contributions to differential diagnosis]. [2019]To compare ability of detection of vascular structures by utilizing ultrasonographic contrast agent (Levovist) prior to and following power Doppler ultrasound (PDUS) and colour Doppler ultrasound (CDUS) and to determine useful parameters in the differentiation of malignant and benign breast masses by means of verified data.
Assessment of breast lesions using Doppler with contrast agents. [2020]To evaluate the use of contrast agents on ultrasound examination of breast lesions and to analyse the capacity of this technique to achieve a differential diagnosis of benign and malignant lesions, using as a pattern a histological study of the lesions.