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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Biopsy
• Intervention / Treatment: Device: Hand-held hybrid probe

• Study Type: Interventional
• Enrollment (Estimated): 335
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debbie Bennett, M.D.; Phone Number: 314-454-7696; Email: debbie.bennett@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Cheryl Herman, M.D.; Phone Number: 314-454-7696; Email: hermanc@wustl.edu
      • Principal Investigator: Debbie Bennett, M.D.
      • Sub-Investigator: Ian Hageman, M.D., Ph.D.
      • Sub-Investigator: JingQin Luo
      • Sub-Investigator: Kimberly Wiele, M.D.
      • Sub-Investigator: Steven Poplack, M.D.
      • Sub-Investigator: Jamiee Mannix, M.D.
      • Sub-Investigator: Quing Zhu, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I - Training Set; 20 patients will be recruited to undergo US-DOT and CEM to allow for training study readers in assessing US-DOT data, intra-observer variability and to assess inter-observer variability in the assessment of US-DOT data; A hand-held hybrid probe will be used for the scans	Device: 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
Experimental: Phase 2: Prospective Trial; 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; Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	-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. Specificity will be calculated as the proportion of subjects with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of subjects 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 (estimated to be 87 months)
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	-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 False Negative Rate will be calculated as the proportion of subjects 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 subjects 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 (estimated to be 87 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debbie Bennett, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201707042; 1R01CA228047-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No