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

Hamamatsu Photonics

Status: Completed

Conditions: Pathology

Treatments: Diagnostic Test: Light Microscopy; Diagnostic Test: Whole Slide Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT03991468

HCT-P001

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

NanoZoomer Whole Slide Imaging

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Whole Slide Imaging

Glass Slide Light Microscopy

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Light Microscopy