Clinical trial · Interventional
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
NCT03077126CI-TRIAL-00026397completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aixplorer® ShearWave Elastography (SWE™) | Device | — | UNRESOLVED |
| Fleet Enema | Other | — | UNRESOLVED |
| Pre-surgery Ultrasound | Diagnostic Test | — | UNRESOLVED |
| Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pre-surgery Ultrasound
- description
- Aixplorer® ShearWave Elastography (SWE™) Ultrasound. Participants will undergo ultrasound prep with Fleet Enema and ultrasound procedure at their pre-op visit one to two weeks before their standard of care prostatectomy.
- interventionNames
- Other: Fleet Enema
- Device: Aixplorer® ShearWave Elastography (SWE™)
- Diagnostic Test: Pre-surgery Ultrasound
- Procedure: Prostatectomy
Primary outcomes (1)
- measure
- Rate of Correlation Between Ultrasound Results and Pathology Results
- timeFrame
- 6 months
- description
- Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center. * Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis. * Location of cancer specified in the pathology report. * Pathology reviewed by Moffitt pathologist Exclusion Criteria: * Less than ten biopsies obtained at time of diagnosis. * Location of cancer not specified. * Pathology not reviewed by Moffitt pathologist.
References
Publications (0)
Data not yet available
No reference posted for this study.