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

Clinical Validation for Feature Detection Precision by WSI Using 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

Study Overview

• Status: Completed
• Conditions: Pathology
• Intervention / Treatment: Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

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 Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210-1063
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NanoZoomer Whole Slide Imaging; Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System	Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System; Detection of pathology features using whole slide imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	1 day

Collaborators and Investigators

• Sponsor: Hamamatsu Photonics K.K.
• Investigators: Principal Investigator: Anil Parwani, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HCT-P002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No