Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

Not Applicable

Completed

• Conditions: Ocular Tumor
• Interventions: Diagnostic Test: Doppler technology

• Registration Number: NCT05051384
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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. 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 Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2022-04-27
• Primary Completion: 2023-04-27
• Study Completion: 2024-01-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraocular tumor	Doppler technology	New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors

Primary Outcome Measures

Name	Time	Method
Qualitative description of the intratumoral microvascular flow	Month 6	Number of visible feeding pedicles

Secondary Outcome Measures

Name	Time	Method
quantification of microvascular flow for each tumor	month 6	Presence or absence of arteriovenous shunts

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France