RetinoblastomaNCT02617862
PCI Imaging System in Pediatric Ophthalmology
A study testing Examination under anaesthetic (EUA), RetCam and COSMOS in people with Retinoblastoma, run by Brenda Gallie at 1 site in Canada.
Trial summary
The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA) to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical Incorporated (PCI) (Pleasanton, CA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Examination under anaesthetic (EUA), RetCam and COSMOS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.
Who cannot join
- Any patient who has a cloudy cornea.
- Any patient whose RetCam imaging exam easily produces blanching of the optic nerve in the normal course of imaging.
- Any patient who has consented to the procedure, but whose course of examination has filled the time allotted, leaving no time to evaluate the COSMOS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina
The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA) to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical Incorporated (PCI) (Pleasanton, CA).
- Conditions
- Retinoblastoma
- Being tested
- Examination under anaesthetic (EUA), RetCam, COSMOS
- Keywords
- Diagnostic imaging, Retina, Pediatrics
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination under anaesthetic (EUA)Procedure or surgery
The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.
RetCamDevice
The RetCam is a pediatric wide-field retinal camera that has been the mainstay for pediatric ophthalmic imaging since 1997. Imaging using the RetCam (during the EUA) is conducted as part of routine clinical magagement.
COSMOSDevice
The COSMOS images will be captured (during the EUA) after the RetCam images. The COSMOS is designed to be used in the same way as the RetCam, but to produce higher quality images.
| Study group | Role | What they receive |
|---|---|---|
| PCI imaging system | Experimental | Not described Receives: Procedure: Examination under anaesthetic (EUA); Device: RetCam; Device: COSMOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the field of view in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Field of view will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Measured: 1 day
Comparison of the color in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Color will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Measured: 1 day
Comparison of the dynamic range in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Dynamic range will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Measured: 1 day
Comparison of the sharpness in RetCam and COSMOS images
Masked investigators will compare images from the RetCam and the COSMOS and grade sharpness on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Measured: 1 day
Comparison of the detail in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Detail will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Measured: 1 day
Comparison of the resolution in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Resolution will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Measured: 1 day
Comparison of the evenness of illumination in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Evenness of illumination will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
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 posted1 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brenda Gallie
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix Clinical Inc.
- Responsible party
- Sponsor-investigator, Brenda Gallie, The Hospital for Sick Children
- Investigators
- Brenda L Gallie, MD, FRCSC, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617862
- Sponsor's protocol ID
- Sickkids
- Status last verified
- Feb 2018
- First submitted
- 5 Nov 2015
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina
- ClinicalTrials.gov ID
- NCT02617862
- Acronym / sponsor ID
- Sickkids
- Conditions
- Retinoblastoma
- Keywords
- Diagnostic imaging, Retina, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brenda GallieUniversity, hospital or other
- Collaborators
- Phoenix Clinical Inc.
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA) to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical Incorporated (PCI) (Pleasanton, CA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI imaging system | Experimental | Procedure: Examination under anaesthetic (EUA), Device: RetCam, Device: COSMOS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| Examination under anaesthetic (EUA)The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions. | Procedure or surgery | PCI imaging system |
| RetCamThe RetCam is a pediatric wide-field retinal camera that has been the mainstay for pediatric ophthalmic imaging since 1997. Imaging using the RetCam (during the EUA) is conducted as part of routine clinical magagement. | Device | PCI imaging system |
| COSMOSThe COSMOS images will be captured (during the EUA) after the RetCam images. The COSMOS is designed to be used in the same way as the RetCam, but to produce higher quality images. | Device | PCI imaging system |
Primary outcome
Comparison of the field of view in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will review images from the RetCam and the COSMOS. Field of view will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Comparison of the color in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will review images from the RetCam and the COSMOS. Color will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Comparison of the dynamic range in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will review images from the RetCam and the COSMOS. Dynamic range will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Comparison of the sharpness in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will compare images from the RetCam and the COSMOS and grade sharpness on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Comparison of the detail in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will review images from the RetCam and the COSMOS. Detail will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Comparison of the resolution in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will review images from the RetCam and the COSMOS. Resolution will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Comparison of the evenness of illumination in RetCam and COSMOS images
Time frame: 1 day
Masked investigators will review images from the RetCam and the COSMOS. Evenness of illumination will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
Results and safety
The study was stopped early (reason given: Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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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.
Brenda L Gallie, MD, FRCSC principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Examination under anaesthetic (EUA), RetCam and COSMOS in people with Retinoblastoma, run by Brenda Gallie at 1 site in Canada.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.). Results are not available in the source record.
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?
Comparison of the field of view in RetCam and COSMOS images (time frame: 1 day). The study lists 7 primary outcomes in all. 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 12 Feb 2018.