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

Hamamatsu Photonics

Status: Completed

Conditions: Pathology

Treatments: Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03992768

HCT-P002

Details and patient eligibility

About

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

Full 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)

Enrollment: 540 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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540 participants in 1 patient group

NanoZoomer Whole Slide Imaging

Experimental group

Description:

Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Treatment:

Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System