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

NCT03842358 | Completed Results DMC FDA Device

• 2 other identifiers: 2017070421R01CA228047-01A1
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Biopsy

Outcome Measures

Primary Outcomes (3)

• 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

  -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.

  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

  -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.

  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

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

Study Arms (1)

US-DOT (US/NIR) Imaging

EXPERIMENTAL

* 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

Device: Hand-held hybrid probe

Interventions

Hand-held hybrid probe DEVICE

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

US-DOT (US/NIR) Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Results Point of Contact

• Title: Debbie Bennett, M.D.
• Organization: Washington University School of Medicine

debbie.bennett@wustl.edu

314-454-7696

Study Officials

• Debbie Bennett, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 15, 2019
• Study Start: March 5, 2019
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)