N/A
N=298
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Breast Biopsy
Bottom Line
View on ClinicalTrials.gov: NCT03842358 ↗Enrolled (actual)
298
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT — 148 BIRADS assessments
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hand-held hybrid probe (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT |
148 | — |
| PRIMARY Impact of US-guided DOT as an Adjunct to Conventional Breast Imaging on Maintaining High Sensitivity as Measured by Comparing the False Negative Rate or Missing Malignancy of Conventional Imaging (CI=US +/- Mammography) Alone Versus CI & US-DOT |
5 | — |
| PRIMARY Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results |
— | — |
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 chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03842358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.