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

Pathology Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991468
• Other study ID #: HCT-P001
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: July 31, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pathology

Intervention

Diagnostic Test:
• Whole Slide Imaging
Scanning of a glass slide to create a digital image that can be viewed on a monitor
• Light Microscopy
Use of traditional light microscopy per institutional standard practice

Locations

Country	Name	City	State
United States	TriCore Reference Laboratories	Albuquerque	New Mexico
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	Major Discordance Rate	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.	1 day