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

Not Applicable

Completed

• Conditions: Pathology
• Interventions: Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

• Registration Number: NCT03992768
• Lead Sponsor: Hamamatsu Photonics K.K.

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)

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-20
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Results First Submitted: 2022-10-31
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Results First Posted: 2022-12-22
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NanoZoomer Whole Slide Imaging	Hamamatsu NanoZoomer S360MD Digital Slide Scanner System	Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States