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The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for pathologists to view, review and diagnose digital images of surgical pathology slides.
The primary endpoint is the indicator of major discordance in primary diagnosis between ground truth case diagnosis and case diagnosis by each modality, WSI and Glass, separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoZoomer Whole Slide Imaging | Experimental | All cases will be assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides. |
|
| Glass Slide Light Microscopy | Active Comparator | All cases will be assessed via the use of traditional light microscopy to assess pathological characteristics of glass slides. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Slide Imaging | Diagnostic Test | Scanning of a glass slide to create a digital image that can be viewed on a monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Discordance Rate | Indpendent reads by four Reading Pathologists (RPs) of both imaging modalitites (8 reads/case) were compared to the original diagnosis ("ground truth" or GT) by an independent adjudication process. This resulted in one of four adjudication outcomes for each read: "Match" (read = GT), "Minor" (minor discordance between read & GT), "Major" (major discordance between read & GT), or "Deferred" (read deferred by RP and excluded from the primary endpoint analysis). The outcome measure was the rate at which major discordances occurred for each modality. | 1 day |
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Inclusion Criteria:
Slide selection for a given case must meet the following criteria:
Exclusion Criteria:
Slides for a given case will be excluded if they meet the following criterion:
• Glass slide that is broken, has abnormal size/thickness, beveled edges, poor coverslip (cracks, waviness, scratches), is sticky, has many pen markings or dirt that cannot be removed, contains air bubbles and overhanging labels that can't be corrected, and if stain is severely faded.
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| Name | Affiliation | Role |
|---|---|---|
| Liron Pantanowitz | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States | ||
| TriCore Reference Laboratories |
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Cases were assessed using both glass slide light microscopy and digital whole slide imaging in a random sequence. Therefore, each case had 2 primary diagnoses in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Cases | All cases will be assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used will be randomly assigned. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Cases | All cases were assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used was randomly assigned. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Major Discordance Rate | Indpendent reads by four Reading Pathologists (RPs) of both imaging modalitites (8 reads/case) were compared to the original diagnosis ("ground truth" or GT) by an independent adjudication process. This resulted in one of four adjudication outcomes for each read: "Match" (read = GT), "Minor" (minor discordance between read & GT), "Major" (major discordance between read & GT), or "Deferred" (read deferred by RP and excluded from the primary endpoint analysis). The outcome measure was the rate at which major discordances occurred for each modality. | Two modalities (glass & WSI) are read by 4 reading pathologists at each site for a total of 16,000 reads. Any reads deferred by a reading pathologist are excluded. | Posted | Number | 95% Confidence Interval | Percentage of Major Discordances | 1 day | Reads | Reads |
|
Because there was no patient involvement in the study and no impact on patient diagnoses, there were no safety endpoints for the study
Because there was no patient involvement in the study and no impact on patient diagnoses, there were no safety endpoints for the study. Therefore no adverse event assessment or monitoring took place.
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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 | All Cases | All cases were assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used was randomly assigned. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MCG Manager | Hamamatsu Photonics, K.K. | +81-53-435-1560 | fujisaka@sys.hpk.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2020 | Oct 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2021 | Nov 30, 2022 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D008853 | Microscopy |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Cases are assessed using both glass slide light microscopy and NanoZoomer digital whole slide imaging in a random order
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Adjudicators are blinded to the imaging modality.
| Light Microscopy | Diagnostic Test | Use of traditional light microscopy per institutional standard practice |
|
| Albuquerque |
| New Mexico |
| 87102 |
| United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210-1063 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Glass Slide Light Microscopy | Use of a traditional light microscope to assess pathological characteristics of glass slides Light Microscopy: Use of traditional light microscopy per institutional standard practice |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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