Ocular TumorSMITISNCT05051384
Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)
A study testing Doppler technology in people with Ocular Tumor, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). Nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ocular Tumor
- What is being tested?
- Doppler technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2022to 18 Jan 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Intraocular tumor not previously treated with proton therapy
Who cannot join
- Severe active ocular, periocular or intraocular inflammation
- Intraocular pressure > 30 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)
The diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). Nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. The study of microvascular flow (Superb Microvascular Imaging, SMI) of intraocular tumors could improve the confidence of differential diagnosis when evaluating these suspicious lesions, or even determine whether a lesion is benign or malignant by describing the vascularization of the lesion.
The investigators propose to study the microvascular flow patterns of intraocular tumors prior to proton therapy.
Read the detailed description
The ultrasound equipment available in ophthalmology does not have Doppler technology and does not allow the study of the vascularization and microvascularization of intraocular lesions. The interest in the system used in this study is to import SMI into ophthalmology to study tumor microvascularization. The study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors.
- Conditions
- Ocular Tumor
- Being tested
- Doppler technology
- Medical subject headings
- Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler technologyDiagnostic test
The study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors
| Study group | Role | What they receive |
|---|---|---|
| Intraocular tumor | Experimental | New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors Receives: Diagnostic Test: Doppler technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative description of the intratumoral microvascular flow
Number of visible feeding pedicles
Measured: Visite 2 - two weeks after Day 0
Qualitative description of the intratumoral microvascular flow
Number of visible feeding pedicles
Measured: Month 6
Secondary outcomes (2)
quantification of microvascular flow for each tumor
Presence or absence of arteriovenous shunts
Measured: Visite 2 2weeks after Day 0
quantification of microvascular flow for each tumor
Presence or absence of arteriovenous shunts
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start27 Apr 2022
- Primary completion27 Apr 2023
- Study completion18 Jan 2026 (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 Centre Hospitalier Universitaire de NiceThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sacha NAHON ESTEVE, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051384
- Sponsor's protocol ID
- 20-AOIP-05
- Other IDs
- 2021-A01289-32
- Acronym
- SMITIS
- Status last verified
- Nov 2025
- First submitted
- 20 Aug 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)
- ClinicalTrials.gov ID
- NCT05051384
- Acronym / sponsor ID
- SMITIS / 20-AOIP-05
- Conditions
- Ocular Tumor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 18 Jan 2026 (estimated)
- First posted
- 21 Sep 2021 (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 diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). Nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. The study of microvascular flow (Superb Microvascular Imaging, SMI) of intraocular tumors could improve the confidence of differential diagnosis when evaluating these suspicious lesions, or even determine whether a lesion is benign or malignant by describing the vascularization of the lesion.
The investigators propose to study the microvascular flow patterns of intraocular tumors prior to proton therapy.
Detailed description
The ultrasound equipment available in ophthalmology does not have Doppler technology and does not allow the study of the vascularization and microvascularization of intraocular lesions. The interest in the system used in this study is to import SMI into ophthalmology to study tumor microvascularization. The study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraocular tumor | Experimental | Diagnostic Test: Doppler technologyNew sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Intraocular tumor not previously treated with proton therapy
Key exclusion criteria (2 listed)
- Severe active ocular, periocular or intraocular inflammation
- Intraocular pressure > 30 mmHg
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 |
|---|---|---|
| Doppler technologyThe study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors | Diagnostic test | Intraocular tumor |
Primary outcome
Qualitative description of the intratumoral microvascular flow
Time frame: Visite 2 - two weeks after Day 0
Number of visible feeding pedicles
Qualitative description of the intratumoral microvascular flow
Time frame: Month 6
Number of visible feeding pedicles
2 secondary outcomes
quantification of microvascular flow for each tumor
Time frame: Visite 2 2weeks after Day 0
quantification of microvascular flow for each tumor
Time frame: month 6
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 3 Dec 2025.
- 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.
Sacha NAHON ESTEVE principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler technology in people with Ocular Tumor, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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 France. 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?
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?
Qualitative description of the intratumoral microvascular flow (time frame: Visite 2 - two weeks after Day 0). 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 3 Dec 2025.