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

NCT03991468 | Completed Results FDA Device

• 1 other identifier: HCT-P001
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pathology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NanoZoomer Whole Slide Imaging

EXPERIMENTAL

All cases will be assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides.

Diagnostic Test: Whole Slide Imaging

Glass Slide Light Microscopy

ACTIVE COMPARATOR

All cases will be assessed via the use of traditional light microscopy to assess pathological characteristics of glass slides.

Diagnostic Test: Light Microscopy

Interventions

Whole Slide Imaging DIAGNOSTIC_TEST

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

Also known as: NanoZoomer Scanning & Imaging

NanoZoomer Whole Slide Imaging

Light Microscopy DIAGNOSTIC_TEST

Use of traditional light microscopy per institutional standard practice

Glass Slide Light Microscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamamatsu Photonics K.K.: lead

Study Sites (4)

Washington University

St Louis, Missouri, 63110, United States

Location

TriCore Reference Laboratories

Albuquerque, New Mexico, 87102, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210-1063, United States

Location

MeSH Terms

Interventions

Diagnostic Imaging; Microscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: MCG Manager
• Organization: Hamamatsu Photonics, K.K.

fujisaka@sys.hpk.co.jp

+81-53-435-1560

Study Officials

• Liron Pantanowitz

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Adjudicators are blinded to the imaging modality.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cases are assessed using both glass slide light microscopy and NanoZoomer digital whole slide imaging in a random order

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: March 15, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)