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

NCT03992768 | Completed Results FDA Device

• 1 other identifier: HCT-P002
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pathology

Outcome Measures

Primary Outcomes (1)

• Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.

  Repeatability and reproducibility of WSI were evaluated using the Average Positive Agreement Rate. Using a comparison of two reads with four possible outcomes (a=both reads detect the feature; b=read 1 fails to detect the feature; c=read 2 fails to detect the feature; d=both reads fail to detect the feature), APA = 2a/(2a+b+c). APA was used to assess outcomes in the following substudies: 1. Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site. 2. Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site 3. Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.

  1 day

Study Arms (1)

NanoZoomer Whole Slide Imaging

EXPERIMENTAL

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

Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Interventions

Hamamatsu NanoZoomer S360MD Digital Slide Scanner System DEVICE

Detection of pathology features using whole slide imaging

NanoZoomer Whole Slide Imaging

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamamatsu Photonics K.K.: lead

Study Sites (3)

Washington University

St Louis, Missouri, 63110, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210-1063, United States

Location

Results Point of Contact

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

fujisaka@sys.hpk.co.jp

+81-53-435-1560

Study Officials

• Anil Parwani, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: June 12, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 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 (3)