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Brief Title: ARFI Imaging for Targeted Prostate Biopsy
Official Title: Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy
Study ID: NCT04607135
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Duke University Medical Center, Durham, North Carolina, United States
Name: Thomas Polascik, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Kathryn Nightingale, PhD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR