NCT03842358

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-03-05
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2019-02-15
• Last updated: 2025-09-26
• Results posted: 2025-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study