CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 298 enrolled
Drug / intervention
Hand-held hybrid probedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03842358
NCT03842358N/ACompleted
CompareCT.gov

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

Washington University School of Medicine·interventional·Posted Feb 15, 2019·Updated Sep 26, 2025

In Brief

A clinical study evaluating Hand-held hybrid probe for Breast Biopsy. Completed, enrolled 298 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Biopsy
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartMar 5, 2019
Primary CompletionJul 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.4 years ago

Interventions

Hand-held hybrid probedevice

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