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

Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992768
• Other study ID #: HCT-P002
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2022
• Source: Hamamatsu Photonics K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pathology

Intervention

Device:
• Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Detection of pathology features using whole slide imaging

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu Photonics K.K.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: 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