Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
2 other identifiers
interventional
99
1 country
1
Brief Summary
This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedMay 2, 2025
May 1, 2025
2.7 years
January 4, 2017
May 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.
At the time of prostate biopsy
Secondary Outcomes (1)
Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
At the time of prostate biopsy
Study Arms (1)
Diagnostic (elastography imaging using the Aixplorer system)
EXPERIMENTALPatients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
Interventions
Undergo ultrasound-based elastography imaging using the Aixplorer system
Undergo ultrasound-based elastography imaging using the Aixplorer system
Undergo standard of care ultrasound-guided prostate biopsy
Eligibility Criteria
You may qualify if:
- Be scheduled for a clinically indicated biopsy of the prostate
- Agree to an ultrasound examination using the Aixplorer system
- Sign an institutional review board (IRB) approved informed consent prior to any study procedures
You may not qualify if:
- Recent prostate biopsy within 90 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ethan Halpern, MD
Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 6, 2017
Study Start
September 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 2, 2025
Record last verified: 2025-05