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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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US-DOT (US/NIR) Imaging

* US-DOT (US/NIR) Imaging Exam
* Breast biopsy or FNA performed (standard of care)
* A hand-held hybrid probe will be used for the scans

Group Type EXPERIMENTAL

Hand-held hybrid probe

Intervention Type DEVICE

Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery

Interventions

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Hand-held hybrid probe

Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No