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

NCT03842358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2025-09-26

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Debbie Bennett, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842358 on ClinicalTrials.gov