PathologyNCT03991468
Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
A study testing Whole Slide Imaging and Light Microscopy in people with Pathology, run by Hamamatsu Photonics K.K. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- What is being tested?
- Whole Slide Imaging and Light Microscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Mar 2019to 31 Jul 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
- Cases originating from and that were diagnosed at that local site
- Cases are available in the site's archive
- Cases are at least 1 year old since accessioning
- Cases are selected because their primary diagnosis is consistent with the assigned target categories
- Cases have a set of slides representative of the primary diagnosis for which it has been selected
- Slide selection for a given case must meet the following criteria:
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- Slide is obtained by surgical pathology and prepared from FFPE human tissue
- Slides must be stained with H\&E and accompanying special stains (histochemical and/or immunohistochemical)
- All special stains slides (histochemical and/or immunohistochemical) where the slide and stain is used for diagnosis, not prognosis.
- A chosen slide must demonstrate and be representative of the primary diagnosis; 1 slide selection may suffice for biopsy cases,
- For resection cases, a minimum of 5 slides must be selected, which represent the primary diagnosis. If represented with less than 5 slides, additional slides (primary, secondary, or benign slides) from same case may be used to fulfill minimum number
- Slide is intact, has correct size/thickness, good edges, undamaged coverslip, without pen markings that can't be removed, no air bubbles, tidy labels, and fulfills the quality checks per the general clinical practice
Who cannot join
- Case does not have relevant slides or if case information necessary for the study is missing
- Case is still active (less than 1 year old) at the local site
- Cases for which the control slides for immunohistochemistry and special stains are not available
- Two cases from same individual
- Gross-only cases that have no slides
- Cases that are frozen section, cytology or hematology or immunofluorescence specimens only
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- Case where the only available set of slides have evidence only of secondary or no diagnoses and not the primary diagnosis for which the case is being screened.
- Slides for a given case will be excluded if they meet the following criterion:
- Glass slide that is broken, has abnormal size/thickness, beveled edges, poor coverslip (cracks, waviness, scratches), is sticky, has many pen markings or dirt that cannot be removed, contains air bubbles and overhanging labels that can't be corrected, and if stain is severely faded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
TriCore Reference Laboratories
Albuquerque, New Mexico, 87102
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 Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope
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.
- Conditions
- Pathology
- Being tested
- Whole Slide Imaging, Light Microscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Slide ImagingDiagnostic test
Also called NanoZoomer Scanning & Imaging
Scanning of a glass slide to create a digital image that can be viewed on a monitor
Light MicroscopyDiagnostic test
Use of traditional light microscopy per institutional standard practice
| Study group | Role | What they receive |
|---|---|---|
| NanoZoomer Whole Slide Imaging | Experimental | 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. Receives: Diagnostic Test: Whole Slide Imaging |
| Glass Slide Light Microscopy | Active comparator | All cases will be assessed via the use of traditional light microscopy to assess pathological characteristics of glass slides. Receives: Diagnostic Test: Light Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Discordance Rate
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.
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 posted19 Jun 2019
- Study start15 Mar 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 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
- Randomised
- Intervention model
- Sequential
- Model description
- Cases are assessed using both glass slide light microscopy and NanoZoomer digital whole slide imaging in a random order
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu Photonics K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liron Pantanowitz, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991468
- Sponsor's protocol ID
- HCT-P001
- 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 Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope
- ClinicalTrials.gov ID
- NCT03991468
- Acronym / sponsor ID
- HCT-P001
- Conditions
- Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Hamamatsu Photonics K.K.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 19 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cases are assessed using both glass slide light microscopy and NanoZoomer digital whole slide imaging in a random order
| Arm | Type | Receives |
|---|---|---|
| NanoZoomer Whole Slide Imaging | Experimental | Diagnostic Test: Whole Slide ImagingAll cases will be assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides. |
| Glass Slide Light Microscopy | Active comparator | Diagnostic Test: Light MicroscopyAll cases will be assessed via the use of traditional light microscopy to assess pathological characteristics of glass slides. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Cases originating from and that were diagnosed at that local site
- Cases are available in the site's archive
- Cases are at least 1 year old since accessioning
- Cases are selected because their primary diagnosis is consistent with the assigned target categories
- Cases have a set of slides representative of the primary diagnosis for which it has been selected
Key exclusion criteria (9 listed)
- Case does not have relevant slides or if case information necessary for the study is missing
- Case is still active (less than 1 year old) at the local site
- Cases for which the control slides for immunohistochemistry and special stains are not available
- Two cases from same individual
- Gross-only cases that have no slides
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 |
|---|---|---|
| Whole Slide ImagingAlso: NanoZoomer Scanning & ImagingScanning of a glass slide to create a digital image that can be viewed on a monitor | Diagnostic test | NanoZoomer Whole Slide Imaging |
| Light MicroscopyUse of traditional light microscopy per institutional standard practice | Diagnostic test | Glass Slide Light Microscopy |
Primary outcome
Major Discordance Rate
Time frame: 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.
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.
Liron Pantanowitz principal investigator
University of Pittsburgh Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Slide Imaging and Light Microscopy in people with Pathology, run by Hamamatsu Photonics K.K. at 4 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 12 inclusion and 9 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 4 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?
Major Discordance Rate (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.