Trial Outcomes & Findings for Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System (NCT NCT03991468)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2000 participants

Primary outcome timeframe

1 day

Results posted on

2022-12-22

Participant Flow

Cases were assessed using both glass slide light microscopy and digital whole slide imaging in a random sequence. Therefore, each case had 2 primary diagnoses in the study.

Participant milestones

Participant milestones
Measure	All Cases 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 and traditional light microscopy using glass slides. The order in which each modality is used will be randomly assigned.
Overall Study STARTED	2000
Overall Study Glass Slide Light Microscopy	2000
Overall Study NanoZoomer Whole Slide Imaging	2000
Overall Study COMPLETED	2000
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Cases n=2000 Participants All cases were assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used was randomly assigned.
Age, Continuous	59.6 Years STANDARD_DEVIATION 14.8 • n=2000 Participants
Sex: Female, Male Female	1046 Participants n=2000 Participants
Sex: Female, Male Male	954 Participants n=2000 Participants
Region of Enrollment United States	2000 participants n=2000 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Two modalities (glass \& WSI) are read by 4 reading pathologists at each site for a total of 16,000 reads. Any reads deferred by a reading pathologist are excluded.

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.

Outcome measures

Outcome measures
Measure	NanoZoomer Whole Slide Imaging n=7997 Reads Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides Whole Slide Imaging: Scanning of a glass slide to create a digital image that can be viewed on a monitor	Glass Slide Light Microscopy n=7998 Reads Use of a traditional light microscope to assess pathological characteristics of glass slides Light Microscopy: Use of traditional light microscopy per institutional standard practice
Major Discordance Rate	3.5 Percentage of Major Discordances Interval 2.6 to 4.7	3.1 Percentage of Major Discordances Interval 2.2 to 4.2

Adverse Events

All Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MCG Manager

Hamamatsu Photonics, K.K.

Phone: +81-53-435-1560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place