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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05158 | Registry Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ExactVu Imaging | Experimental | EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExactVu | Device | clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology | 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) | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Cancer Border Identification Post-Prostatectomy | Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy. | 3 years |
| Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Sonn | Stanford Universiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 95304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076245 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ExactVu Imaging | EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ExactVu Imaging | EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology | 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) | Posted | Number | participants | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days) |
|
up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ExactVu Imaging | EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geoffrey Sonn | Stanford University | (650) 498-6000 | gsonn@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2021 | Jan 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2022 | Jun 10, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6) |
| 1 year and 10 months |
| Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI). | 1 year and 10 months |
| Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation | Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy | 3 years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Prostate Cancer Border Identification Post-Prostatectomy | Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy. | No participants were analyzed for this outcome. The slide scanning platform was deprecated during the study period, and specimens were collected during the transition between platforms. As a result, slides were not digitized and tumor border correlation with imaging could not be performed. | Posted | 3 years |
|
|
| Secondary | Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) | Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6) | Posted | Number | percentage of agreement | 1 year and 10 months |
|
|
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| Secondary | Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI). | This analysis includes all participants evaluated for prostate cancer detection using micro-ultrasound (MUS) and multiparametric MRI (mpMRI). Metrics include sensitivity and inter-reader agreement (κ values), reported as percentages for consistency | Posted | Mean | Standard Error | percentage of agreement | 1 year and 10 months |
|
|
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| Secondary | Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation | Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy | No participants were analyzed for this outcome. The slide scanning platform was deprecated during the study period, and specimens were collected during the transition between platforms. As a result, slides were not digitized and imaging-pathology correlation could not be performed. | Posted | 3 years |
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| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Average mpMRI Inter-Reader Agreement (κ) |
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