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

Not Applicable

Completed

Conditions: Breast Biopsy

Registration Number: NCT03842358

Lead Sponsor: Washington University School of Medicine

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 298

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient	-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Benign biopsy reduction will be calculated as the proportion of reads (CI \& US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads with no cancer demonstrated at biopsy. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist.
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	Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient	-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. The engineering team is also blinded to the biopsy exam and pathology outcomes. The False Negative Rate will be calculated as the proportion of reads with a non-suspicious assessment i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', who have cancer (defined as Invasive cancer or Ductal Carcinoma In Situ) demonstrated at biopsy divided by the denominator of all reads with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist.
Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results	Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Washington University School of Medicine
🇺🇸
St Louis, Missouri, United States
Washington University School of Medicine
🇺🇸St Louis, Missouri, United States