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

NCT02432820 | Terminated

• 2 other identifiers: IRB-33012PROS0070
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

SPECIFIC STUDY AIMS

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients being treated at Stanford Cancer Center

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Philips Healthcare: collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dimitre Hristov

  Stanford University

  PRINCIPAL INVESTIGATOR

• Steven Hancock

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 4, 2015
• Study Start: April 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

US (1)