NCT04607135

ARFI Imaging for Targeted Prostate Biopsy

Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Acoustic radiation force impulse (ARFI)	Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system
DEVICE	Ultrasound	Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen

Timeline

• Start date: 2021-10-22
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2020-10-29
• Last updated: 2025-05-06
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study