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Trial record 1 of 1 for:    steven hancock | Prostate Cancer
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Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432820
Recruitment Status : Terminated (Business decision)
First Posted : May 4, 2015
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date April 16, 2015
First Posted Date May 4, 2015
Last Update Posted Date April 10, 2017
Study Start Date April 2015
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2015)
  • Changes in dose-volume histogram (DVH) indices in prostate images [ Time Frame: 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 bladder images [ Time Frame: 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.
  • Changes in dose-volume histogram (DVH) indices in rectal wall images [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02432820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy
Official Title Assessment of 3D Transperineal Ultrasound Imaging With Matrix Array Transducers as a Potential Imaging Modality for Adaptive Prostate and Post-Prostatectomy Radiotherapy
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Prostate cancer patients being treated at Stanford Cancer Center
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 6, 2017)
7
Original Estimated Enrollment
 (submitted: April 28, 2015)
10
Actual Study Completion Date September 30, 2016
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02432820
Other Study ID Numbers PROS0070
33012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Philips Healthcare
Investigators
Principal Investigator: Dimitre Hristov Stanford University
Principal Investigator: Steven Hancock Stanford University
PRS Account Stanford University
Verification Date April 2017