Status:
COMPLETED
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Biopsy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant che...
Eligibility Criteria
Inclusion
- Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3\*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration
- \*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).
- Willing and able to provide informed consent
Exclusion
- Lesions located in the darkly pigmented nipple-areolar complex area
- Subjects with breast implants
- Abnormality in the mirror image location of the contralateral breast.
- Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy
- Previous breast irradiation of the mirror image location of the contralateral breast
- Lesions located at previous biopsy sites when biopsy occurred within the last six months.
- Pregnancy
- Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT03842358
Start Date
March 5 2019
End Date
July 30 2024
Last Update
September 26 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110