Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
NCT ID: NCT03013413
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2011-09-30
2014-05-31
Brief Summary
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Detailed Description
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I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.
SECONDARY OBJECTIVES:
I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.
II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (elastography imaging using the Aixplorer system)
Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
Shear Wave Elastography
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound Elasticity Imaging
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound-Guided Prostate Biopsy
Undergo standard of care ultrasound-guided prostate biopsy
Interventions
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Shear Wave Elastography
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound Elasticity Imaging
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound-Guided Prostate Biopsy
Undergo standard of care ultrasound-guided prostate biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agree to an ultrasound examination using the Aixplorer system
* Sign an institutional review board (IRB) approved informed consent prior to any study procedures
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Ethan Halpern, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Sidney Kimmel Cancer Center
Thomas Jefferson University Hospital
Other Identifiers
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JT 1614
Identifier Type: OTHER
Identifier Source: secondary_id
11D.349
Identifier Type: -
Identifier Source: org_study_id
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