NCT03991468

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

Completed NA Results posted Last updated 22 December 2022

What this trial tests

NA trial testing Whole Slide Imaging in Pathology in 2,000 participants. Completed in 31 July 2021.

Timeline

15 March 2019

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	Hamamatsu Photonics K.K.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	diagnostic
Enrollment	2,000
Start date	15 March 2019
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	4 locations across United States

Drugs / interventions tested

• Whole Slide Imaging
• Light Microscopy

Conditions studied

• Pathology — all drugs for Pathology →

Sponsor

Hamamatsu Photonics K.K. — full company profile →

Who can join

Eligibility, any sex, with Pathology. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Major Discordance Rate Primary · 1 day

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.

Group	Value	95% CI
NanoZoomer Whole Slide Imaging	3.5	2.6 – 4.7
Glass Slide Light Microscopy	3.1	2.2 – 4.2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.