CompletedNot Applicable

Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography

United States298 participantsStarted 2019-03-05

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

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

Timeframe: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results

Timeframe: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

Trial details

NCT IDNCT03842358

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-30

Results submitted2025-07-29

View on ClinicalTrials.gov More Breast Biopsy trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results

Timeframe: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient