Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shear Wave Elastography | Procedure | — | UNRESOLVED |
| Ultrasound Elasticity Imaging | Procedure | — | UNRESOLVED |
| Ultrasound-Guided Prostate Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (elastography imaging using the Aixplorer system)
- description
- Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
- interventionNames
- Procedure: Shear Wave Elastography
- Procedure: Ultrasound Elasticity Imaging
- Procedure: Ultrasound-Guided Prostate Biopsy
Primary outcomes (1)
- measure
- Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
- timeFrame
- At the time of prostate biopsy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: • Recent prostate biopsy within 90 days
References
Publications (0)
Data not yet available