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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04981223
Recruitment Status : Not yet recruiting
First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: ExactVu Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ExactVu Imaging

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
Device: ExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging




Primary Outcome Measures :
  1. Diagnostic accuracy of micro-ultrasound biopsy and prostatectomy patients. [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Rate of adequately identified (positive or negative) lesions of prostate cancer will be measured


Secondary Outcome Measures :
  1. Morphology of lesions detected by mirco-resolution ultrasound [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Hausdoff distance between the ultrasound lesion and pathology lesions would be measured and reported in mm.

  2. Volume from systematic and targeted cores [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Volume of cancer from individual biopsy cores will be reported

  3. Sensitivity of micro-ultrasound and multiparametric MRI [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Sensitivity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported

  4. Measuring correlation between Prostatectomy pathology and imaging correlation [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy. For prostatectomy specimens, Dice score will be computed, comparing the pixel-wise labels from the annotated pathology specimen to the annotations on multi-parametric magnetic resonance imaging (mpMRI) and micro-ultrasound (this is a unit-less coefficient).Hausdorff Distance, which will give us the greatest distance between the overlapping lesions, with units in millimeters will be reported

  5. Specificity of micro-ultrasound and multiparametric MRI [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Specificity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported

  6. Negative predictive values of high-resolution ultrasound and multiparametric MRI [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Negative predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported

  7. Positive predictive values of high-resolution ultrasound and multiparametric [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Positive predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported

  8. Location from systematic and targeted cores [ Time Frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days ]
    Location of cancer from individual biopsy cores will be reported



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981223


Contacts
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Contact: Ned U Realiza 650-498-8496 nrealiza@stanford.edu

Locations
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United States, California
Stanford University
Stanford, California, United States, 95304
Contact: Ned U Realiza         
Contact: Geoffrey Sonn         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Geoffrey Sonn Stanford Universiy
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04981223    
Other Study ID Numbers: IRB-58101
PROS0104 ( Other Identifier: OnCore )
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases