Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging

Stanford University

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Device: ExactVu

Study type: Interventional

Funder types: Other

Identifiers

NCT04981223

IRB-58101

NCI-2022-05158 (Registry Identifier)

Details and patient eligibility

About

The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.

Enrollment: 95 patients

Sex: Male

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
• Agree to consent to the study

Exclusion criteria

• Does not agree to consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

95 participants in 1 patient group

ExactVu Imaging

Experimental group

Description:

EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: 1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy

Treatment:

Device: ExactVu