Trial Outcomes & Findings for Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System (NCT NCT03992768)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

540 participants

Primary outcome timeframe

1 day

Results posted on

2022-12-22

Participant Flow

Unit of analysis: Features

Participant milestones

Participant milestones
Measure	NanoZoomer Whole Slide Imaging Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging
Overall Study STARTED	540 540
Overall Study COMPLETED	540 540
Overall Study NOT COMPLETED	0 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	NanoZoomer Whole Slide Imaging n=540 Participants Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging
Region of Enrollment United States	540 Participants n=540 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Intra-scanner Precision: 3 separate scans on 1 scanner of 378 features read by 3 reading pathologists in 3 sessions each Inter-scanner Precision: 1 scan each of 378 features on 3 scanners read by 3 reading pathologists in 3 sessions each Inter-site Precision: 378 FOVs scanned on 1 scanner read by 3 reading pathologists at 3 sites in 1 session each

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.

Outcome measures

Outcome measures
Measure	NanoZoomer Whole Slide Imaging - Intra-scanner Precision n=3402 Reads Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging	NanoZoomer Whole Slide Imaging - Inter-scanner Precision n=3402 Reads Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging	NanoZoomer Whole Slide Imaging - Inter-site Precision n=1134 Reads Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging
Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.	94.5 Average Positive Agreement Rate Interval 93.7 to 95.3	92.4 Average Positive Agreement Rate Interval 90.7 to 93.9	93.4 Average Positive Agreement Rate Interval 91.9 to 94.9

Adverse Events

NanoZoomer Whole Slide Imaging

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