Clinical trial · Interventional
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
NCT04981223CI-TRIAL-00112776completedN/AResults postedClinicalTrials.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 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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExactVu | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ExactVu Imaging
- description
- EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: 1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 2. 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
- interventionNames
- Device: ExactVu
Primary outcomes (1)
- measure
- Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
- timeFrame
- From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
- description
- Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTZhou SR, Choi MH, Vesal S, Kinnaird A, Brisbane WG, Lughezzani G, Maffei D, Fasulo V, Albers P, Zhang L, Kornberg Z, Fan RE, Shao W, Rusu M, Sonn GA. Inter-reader Agreement for Prostate Cancer Detection Using Micro-ultrasound: A Multi-institutional Study. Eur Urol Open Sci. 2024 Jul 13;66:93-100. doi: 10.1016/j.euros.2024.06.017. eCollection 2024 Aug. PMID 39076245