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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExactVu
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExactVu Imaging

Arm Description

EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 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

Outcomes

Primary Outcome Measures

Diagnostic accuracy of micro-ultrasound biopsy and prostatectomy patients.
Rate of adequately identified (positive or negative) lesions of prostate cancer will be measured

Secondary Outcome Measures

Morphology of lesions detected by mirco-resolution ultrasound
Hausdoff distance between the ultrasound lesion and pathology lesions would be measured and reported in mm.
Volume from systematic and targeted cores
Volume of cancer from individual biopsy cores will be reported
Sensitivity of micro-ultrasound and multiparametric MRI
Sensitivity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Measuring correlation between Prostatectomy pathology and imaging correlation
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
Specificity of micro-ultrasound and multiparametric MRI
Specificity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Negative predictive values of high-resolution ultrasound and multiparametric MRI
Negative predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Positive predictive values of high-resolution ultrasound and multiparametric
Positive predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Location from systematic and targeted cores
Location of cancer from individual biopsy cores will be reported

Full Information

First Posted
July 9, 2021
Last Updated
July 18, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04981223
Brief Title
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Official Title
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ExactVu Imaging
Arm Type
Experimental
Arm Description
EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 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
Intervention Type
Device
Intervention Name(s)
ExactVu
Intervention Description
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Primary Outcome Measure Information:
Title
Diagnostic accuracy of micro-ultrasound biopsy and prostatectomy patients.
Description
Rate of adequately identified (positive or negative) lesions of prostate cancer will be measured
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Secondary Outcome Measure Information:
Title
Morphology of lesions detected by mirco-resolution ultrasound
Description
Hausdoff distance between the ultrasound lesion and pathology lesions would be measured and reported in mm.
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Volume from systematic and targeted cores
Description
Volume of cancer from individual biopsy cores will be reported
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Sensitivity of micro-ultrasound and multiparametric MRI
Description
Sensitivity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Measuring correlation between Prostatectomy pathology and imaging correlation
Description
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
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Specificity of micro-ultrasound and multiparametric MRI
Description
Specificity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Negative predictive values of high-resolution ultrasound and multiparametric MRI
Description
Negative predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Positive predictive values of high-resolution ultrasound and multiparametric
Description
Positive predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days
Title
Location from systematic and targeted cores
Description
Location of cancer from individual biopsy cores will be reported
Time Frame
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ned U Realiza
Phone
650-498-8496
Email
nrealiza@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Sonn
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
95304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ned U Realiza
First Name & Middle Initial & Last Name & Degree
Geoffrey Sonn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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