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Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

NCT06171607 · University of Southern California
In plain English

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Official title
Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-11-05
Estimated completion: 2027-11-05
Last updated: 2026-02-02
Interventions
Procedure: Contrast-Enhanced UltrasoundDrug: Perflutren Lipid MicrospheresDrug: Sulfur Hexafluoride Lipid Microspheres
Primary outcomes
  • Radiomics-based ML-classifier framework (Up to 12 months)
  • Performance of radiomics-based ML approach to prevent unnecessary biopsies (Up to 12 months)
Sponsor
University of Southern California · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactJanet Jaime · contact · Janet.jaime@med.usc.edu · 323-865-3205
InvestigatorBino A Varghese, PhD · principal_investigator, University of Southern California
All locations (2)
Los Angeles County-USC Medical CenterRecruiting
Los Angeles, California, United States
USC / Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses · TrialPath