Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)

Conditions
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Ocular Tumor

Intervention / Treatment
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* Diagnostic Test: Doppler technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Intraocular tumor not previously treated with proton therapy Exclusion Criteria: Severe active ocular, periocular or intraocular inflammation Intraocular pressure > 30 mmHg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraocular tumor<br>New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors | Diagnostic Test: Doppler technology<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative description of the intratumoral microvascular flow | Number of visible feeding pedicles | Visite 2 - two weeks after Day 0 | 
| Qualitative description of the intratumoral microvascular flow | Number of visible feeding pedicles | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantification of microvascular flow for each tumor | Presence or absence of arteriovenous shunts | Visite 2 2weeks after Day 0 | 
| quantification of microvascular flow for each tumor | Presence or absence of arteriovenous shunts | month 6 |