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

Prostate Cancer Clinical Trial

Official title:

Assessment of 3D Transperineal Ultrasound Imaging With Matrix Array Transducers as a Potential Imaging Modality for Adaptive Prostate and Post-Prostatectomy Radiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02432820
• Other study ID #: IRB-33012
• Secondary ID: PROS0070
• Status: Terminated
• Start date: April 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: June 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in dose-volume histogram (DVH) indices in prostate images	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.	1 year
Primary	Changes in dose-volume histogram (DVH) indices in bladder images	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.	1 year
Primary	Changes in dose-volume histogram (DVH) indices in rectal wall images	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.	1 year