Ocular TumorNCT07449195
A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors
A study testing Intalight Dream OCT and Heidelberg Spectralis OCT in people with Ocular Tumor, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to compare two devices used for optical coherence tomography (OCT). OCT is a noninvasive imaging (scanning) method that uses reflected light to create pictures of the back of the eye, and doctors can use OCT to detect and monitor different types of cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Tumor
- What is being tested?
- Intalight Dream OCT and Heidelberg Spectralis OCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Feb 2026to 27 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- At least 1 eye that has an intraocular or ocular surface tumor.
- The presence of a natural crystalline lens or intraocular lens.
- Pupils that can dilate up to at least 3 mm in the study eyes.
- The absence of opaque natural crystalline lenses or the presence of any ocular disease that prevents the view of the retina for imaging.
- Patients must be able to fixate on the imaging target.
- Patients must be able to sit still for a period of time (approximately 2 minutes).
Who cannot join
- Does not meet ALL of the above conditions
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, 11553
Jasmine Francis, MD, 212-639-7266
About this study
Official title: Ocular Imaging for Monitoring of Ocular Tumor Disease
The purpose of this study is to compare two devices used for optical coherence tomography (OCT). OCT is a noninvasive imaging (scanning) method that uses reflected light to create pictures of the back of the eye, and doctors can use OCT to detect and monitor different types of cancer
- Conditions
- Ocular Tumor
- Being tested
- Intalight Dream OCT, Heidelberg Spectralis OCT
- Keywords
- Ocular Tumors, 25-314, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intalight Dream OCTDiagnostic test
This is a next-generation swept-source device that has a faster imaging speed and higher sensitivity than the previous generation of frequency-domain OCT devices, which serve as the current standard of care devices.
Heidelberg Spectralis OCTDiagnostic test
This is the standard of care for optical imaging.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Ocular Tumor | Experimental | Participants will have at least 1 eye that has an intraocular or ocular surface tumor. Receives: Diagnostic Test: Intalight Dream OCT; Diagnostic Test: Heidelberg Spectralis OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality for participants
Evaluated by next-generation swept-source OCT versus standard OCT for imaging of the eye and any relevant ocular tumors.
Measured: Up to 1 year
Field of view for participants
Evaluated by next-generation swept-source OCT versus standard OCT for imaging of the eye and any relevant ocular tumors.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start27 Feb 2026
- Primary completion27 Feb 2028 (estimated)
- Study completion27 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Intalight, Inc
- Responsible party
- Sponsor
- Investigators
- Jasmine Francis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449195
- Sponsor's protocol ID
- 25-314
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Imaging for Monitoring of Ocular Tumor Disease
- ClinicalTrials.gov ID
- NCT07449195
- Acronym / sponsor ID
- 25-314
- Conditions
- Ocular Tumor
- Keywords
- Ocular Tumors, 25-314, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Intalight, Inc
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 27 Feb 2028 (estimated)
- Study completion
- 27 Feb 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- 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 two devices used for optical coherence tomography (OCT). OCT is a noninvasive imaging (scanning) method that uses reflected light to create pictures of the back of the eye, and doctors can use OCT to detect and monitor different types of cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Ocular Tumor | Experimental | Diagnostic Test: Intalight Dream OCT, Diagnostic Test: Heidelberg Spectralis OCTParticipants will have at least 1 eye that has an intraocular or ocular surface tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- At least 1 eye that has an intraocular or ocular surface tumor.
- The presence of a natural crystalline lens or intraocular lens.
- Pupils that can dilate up to at least 3 mm in the study eyes.
- The absence of opaque natural crystalline lenses or the presence of any ocular disease that prevents the view of the retina for imaging.
Key exclusion criteria (1 listed)
- Does not meet ALL of the above conditions
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 |
|---|---|---|
| Intalight Dream OCTThis is a next-generation swept-source device that has a faster imaging speed and higher sensitivity than the previous generation of frequency-domain OCT devices, which serve as the current standard of care devices. | Diagnostic test | Participants with Ocular Tumor |
| Heidelberg Spectralis OCTThis is the standard of care for optical imaging. | Diagnostic test | Participants with Ocular Tumor |
Primary outcome
Image quality for participants
Time frame: Up to 1 year
Evaluated by next-generation swept-source OCT versus standard OCT for imaging of the eye and any relevant ocular tumors.
Field of view for participants
Time frame: Up to 1 year
Evaluated by next-generation swept-source OCT versus standard OCT for imaging of the eye and any relevant ocular tumors.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Jasmine Francis, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intalight Dream OCT and Heidelberg Spectralis OCT in people with Ocular Tumor, run by Memorial Sloan Kettering Cancer Center at 7 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Francis, MD (212-639-7266, francij1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality for participants (time frame: Up to 1 year). The study lists 2 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 13 May 2026.