Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging

Completed

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Key information

Conditions

Pathology

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University, St Louis, Missouri, United States

About this study

The study will be conducted under the following 3 sub-studies:

Scans within Scanner (Intra-scanner precision substudy),
Scanners within a site (Inter-scanner precision substudy),
Scanners between sites (Inter-site precision substudy)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Device

Detection of pathology features using whole slide imaging

Primary outcomes

Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.

Time frame: 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:
- Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site.
- Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site
- Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.

Sponsors and collaborators

Lead sponsor

Hamamatsu Photonics K.K.

Industry

Registry information

Official study title

Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jun 20, 2019
Registry last updated: Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed