Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics
Description
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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- Contraindications to microbubble contrast: Patients who have a known pulmonary hypertension and any known hypersensitivity to US contrast agent
- Women who are pregnant, possibly pregnant, or lactating
- Women currently undergoing neoadjuvant chemotherapy
- Women < 18 years of age
- 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
- Prior history of biopsy for that specific lesion
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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