Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for pathologists to view, review and diagnose digital images of surgical pathology slides.

The primary endpoint is the indicator of major discordance in primary diagnosis between ground truth case diagnosis and case diagnosis by each modality, WSI and Glass, separately.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Cases originating from and that were diagnosed at that local site
Cases are available in the site's archive
Cases are at least 1 year old since accessioning
Cases are selected because their primary diagnosis is consistent with the assigned target categories
Cases have a set of slides representative of the primary diagnosis for which it has been selected

Slide selection for a given case must meet the following criteria:

Slide is obtained by surgical pathology and prepared from FFPE human tissue
Slides must be stained with H&E and accompanying special stains (histochemical and/or immunohistochemical)
All special stains slides (histochemical and/or immunohistochemical) where the slide and stain is used for diagnosis, not prognosis.
A chosen slide must demonstrate and be representative of the primary diagnosis; 1 slide selection may suffice for biopsy cases,
For resection cases, a minimum of 5 slides must be selected, which represent the primary diagnosis. If represented with less than 5 slides, additional slides (primary, secondary, or benign slides) from same case may be used to fulfill minimum number
Slide is intact, has correct size/thickness, good edges, undamaged coverslip, without pen markings that can't be removed, no air bubbles, tidy labels, and fulfills the quality checks per the general clinical practice

Exclusion criteria

Case does not have relevant slides or if case information necessary for the study is missing
Case is still active (less than 1 year old) at the local site
Cases for which the control slides for immunohistochemistry and special stains are not available
Two cases from same individual
Gross-only cases that have no slides
Cases that are frozen section, cytology or hematology or immunofluorescence specimens only
Case where the only available set of slides have evidence only of secondary or no diagnoses and not the primary diagnosis for which the case is being screened.

Slides for a given case will be excluded if they meet the following criterion:

Glass slide that is broken, has abnormal size/thickness, beveled edges, poor coverslip (cracks, waviness, scratches), is sticky, has many pen markings or dirt that cannot be removed, contains air bubbles and overhanging labels that can't be corrected, and if stain is severely faded.

Treatment and study plan

Whole Slide Imaging

Diagnostic Test

Scanning of a glass slide to create a digital image that can be viewed on a monitor

Other names: NanoZoomer Scanning & Imaging

Light Microscopy

Diagnostic Test

Use of traditional light microscopy per institutional standard practice

Primary outcomes

Major Discordance Rate

Time frame: 1 day

Indpendent reads by four Reading Pathologists (RPs) of both imaging modalitites (8 reads/case) were compared to the original diagnosis ("ground truth" or GT) by an independent adjudication process. This resulted in one of four adjudication outcomes for each read: "Match" (read = GT), "Minor" (minor discordance between read & GT), "Major" (major discordance between read & GT), or "Deferred" (read deferred by RP and excluded from the primary endpoint analysis). The outcome measure was the rate at which major discordances occurred for each modality.

Sponsors and collaborators

Lead sponsor

Hamamatsu Photonics K.K.

Industry

Registry information

Official study title

Clinical Validation for Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jun 19, 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