Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT02432820
• Lead Sponsor: Stanford University

Brief Summary

SPECIFIC STUDY AIMS

1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.

2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.

Detailed Description

SPECIFIC STUDY AIMS

1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.

2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

• Men that will undergo prostate radiotherapy as a primary treatment or post-prostatectomy.
• Age 18 or older
• Ability to understand and sign informed consent

Exclusion Criteria

• Younger than 18 yrs old
• Inability to provide written and spoken consent.
• Patients with implanted actively controlled devices that may be subject to electromagnetic interference from the UroNav/PervuNav electromagnetic tracking used in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in dose-volume histogram (DVH) indices in prostate images	1 year	The overall purpose of this study is to evaluate the ability of 3D ultrasound (US) to visualize the prostate with sufficient clarity and reliability to monitor and model anatomy motion and deformation. If this research study is successful in its findings, this mode of ultrasound imaging will have the ability to be adapted for the purposes of cost-efficient prostate radiotherapy.
Changes in dose-volume histogram (DVH) indices in rectal wall images	1 year	The overall purpose of this study is to evaluate the ability of 3D ultrasound (US) to visualize the rectal wall with sufficient clarity and reliability to monitor and model anatomy motion and deformation. If this research study is successful in its findings, this mode of ultrasound imaging will have the ability to be adapted for the purposes of cost-efficient prostate radiotherapy.
Changes in dose-volume histogram (DVH) indices in bladder images	1 year	The overall purpose of this study is to evaluate the ability of 3D ultrasound (US) to visualize the bladder with sufficient clarity and reliability to monitor and model anatomy motion and deformation. If this research study is successful in its findings, this mode of ultrasound imaging will have the ability to be adapted for the purposes of cost-efficient prostate radiotherapy.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States