Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
NCT ID: NCT04981223
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
95 participants
INTERVENTIONAL
2022-04-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ExactVu Imaging
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
ExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Interventions
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ExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Eligibility Criteria
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Inclusion Criteria
* Agree to consent to the study
Exclusion Criteria
18 Years
89 Years
MALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Geoffrey Sonn
Associate Professor of Urology
Principal Investigators
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Geoffrey Sonn
Role: PRINCIPAL_INVESTIGATOR
Stanford Universiy
Locations
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Stanford University
Stanford, California, United States
Countries
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References
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Zhou 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2022-05158
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-58101
Identifier Type: -
Identifier Source: org_study_id
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