N/A
N=540
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Pathology
Bottom Line
View on ClinicalTrials.gov: NCT03992768 ↗Enrolled (actual)
540
Serious AEs
—
Results posted
Dec 2022
Primary outcome: Primary: Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. — 94.5; 92.4; 93.4 Average Positive Agreement Rate
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hamamatsu Photonics K.K.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. |
94.5; 92.4; 93.4 | — |
Summary
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03992768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.