Pathology
Conditions
Brief summary
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
Detailed description
The study will be conducted under the following 3 sub-studies: 1. Scans within Scanner (Intra-scanner precision substudy), 2. Scanners within a site (Inter-scanner precision substudy), 3. Scanners between sites (Inter-site precision substudy)
Interventions
DEVICEHamamatsu NanoZoomer S360MD Digital Slide Scanner System
Detection of pathology features using whole slide imaging
Sponsors
Hamamatsu Photonics K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Glass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply: * Slides are selected from cases in a consecutive manner starting with cases at least 1 year old since accessioning * Slide is a glass cover-slipped surgical pathology slide of human tissue * Slide is stained with hematoxylin and eosin (H&E) or other stains * Slide has the designated primary feature in the FOV, which is readily observable in its natural environment although the slide may also have one or more secondary features from the same magnification group in the FOV. * Slide is available in the archives for use, or purchased commercially, is not damaged, has tissue on the slide which is still in good condition, has a stain that is not faded and otherwise passes all quality checks
Exclusion criteria
Slides are to be excluded from the study if any of the following criteria apply: * Slide is unable to be scanned, contains damaged tissue or has indelible markings * Slide comes from an active (less than 1 year old) case * Slide is from a patient who already has a slide enrolled in the study, only 1 slide per patient to be enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. | 1 day | Repeatability and reproducibility of WSI were evaluated using the Average Positive Agreement Rate. Using a comparison of two reads with four possible outcomes (a=both reads detect the feature; b=read 1 fails to detect the feature; c=read 2 fails to detect the feature; d=both reads fail to detect the feature), APA = 2a/(2a+b+c). APA was used to assess outcomes in the following substudies: 1. Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site. 2. Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site 3. Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NanoZoomer Whole Slide Imaging Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging | 540 |
| Total | 540 |
Baseline characteristics
| Characteristic | — | NanoZoomer Whole Slide Imaging |
|---|---|---|
| Race and Ethnicity Not Collected | — Participants | — |
| Region of Enrollment United States | — | 540 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.
Repeatability and reproducibility of WSI were evaluated using the Average Positive Agreement Rate. Using a comparison of two reads with four possible outcomes (a=both reads detect the feature; b=read 1 fails to detect the feature; c=read 2 fails to detect the feature; d=both reads fail to detect the feature), APA = 2a/(2a+b+c). APA was used to assess outcomes in the following substudies: 1. Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site. 2. Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site 3. Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.
Time frame: 1 day
Population: Intra-scanner Precision: 3 separate scans on 1 scanner of 378 features read by 3 reading pathologists in 3 sessions each Inter-scanner Precision: 1 scan each of 378 features on 3 scanners read by 3 reading pathologists in 3 sessions each Inter-site Precision: 378 FOVs scanned on 1 scanner read by 3 reading pathologists at 3 sites in 1 session each
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NanoZoomer Whole Slide Imaging - Intra-scanner Precision | Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. | 94.5 Average Positive Agreement Rate |
| NanoZoomer Whole Slide Imaging - Inter-scanner Precision | Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. | 92.4 Average Positive Agreement Rate |
| NanoZoomer Whole Slide Imaging - Inter-site Precision | Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. | 93.4 Average Positive Agreement Rate |