Clinical trial NCT03842358: Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Official title: Improving Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Biopsy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-15
Enrollment: 293
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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 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.
* Small lesions of less than 1 cm located at skin or close to the skin
* Pregnancy
* Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin

Primary outcomes:
measure: Impact of US-guided DOT on the potential reduction of benign biopsies as measured by comparing the specificity of conventional imaging (CI = US +/- Mammography) alone versus CI & US-DOT
timeFrame: Completion of enrollment for all patients (estimated to be 87 months)
measure: Impact of US-guided DOT as an adjunct to conventional breast imaging on maintaining high sensitivity as measured by comparing the false negative rate of conventional imaging (CI=US +/- Mammography) alone versus CI & US-DOT
timeFrame: Completion of enrollment for all patients (estimated to be 87 months)
measure: Impact of adjunctive US-guided DOT data in the management of discordant pathology results
timeFrame: Completion of enrollment for all patients (estimated to be 87 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Debbie Bennett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: