PathologyNCT03992768
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
A study testing Hamamatsu NanoZoomer S360MD Digital Slide Scanner System in people with Pathology, run by Hamamatsu Photonics K.K. at 3 sites in United States.
Trial summary
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- What is being tested?
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jun 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210-1063
Washington University
St Louis, Missouri, 63110
About this study
Official title: Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
Read the detailed description
The study will be conducted under the following 3 sub-studies:
- Scans within Scanner (Intra-scanner precision substudy),
- Scanners within a site (Inter-scanner precision substudy),
- Scanners between sites (Inter-site precision substudy)
- Conditions
- Pathology
- Being tested
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamamatsu NanoZoomer S360MD Digital Slide Scanner SystemDevice
Detection of pathology features using whole slide imaging
| Study group | Role | What they receive |
|---|---|---|
| NanoZoomer Whole Slide Imaging | Experimental | Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Receives: Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site.
- Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site
- Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start12 Jun 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu Photonics K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anil Parwani, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992768
- Sponsor's protocol ID
- HCT-P002
- Status last verified
- Nov 2022
- First submitted
- 18 Jun 2019
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- ClinicalTrials.gov ID
- NCT03992768
- Acronym / sponsor ID
- HCT-P002
- Conditions
- Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Hamamatsu Photonics K.K.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
Detailed description
The study will be conducted under the following 3 sub-studies:
- Scans within Scanner (Intra-scanner precision substudy),
- Scanners within a site (Inter-scanner precision substudy),
- Scanners between sites (Inter-site precision substudy)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NanoZoomer Whole Slide Imaging | Experimental | Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner SystemWhole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamamatsu NanoZoomer S360MD Digital Slide Scanner SystemDetection of pathology features using whole slide imaging | Device | NanoZoomer Whole Slide Imaging |
Primary outcome
Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.
Time frame: 1 day
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Parwani, MD principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamamatsu NanoZoomer S360MD Digital Slide Scanner System in people with Pathology, run by Hamamatsu Photonics K.K. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.