Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05051384

Acronym

SMITIS

Enrollment

Registered

2021-09-21

Start date

2022-04-27

Completion date

2026-01-18

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Tumor

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.

Interventions

DIAGNOSTIC_TESTDoppler technology

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

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Qualitative description of the intratumoral microvascular flow	Visite 2 - two weeks after Day 0	Number of visible feeding pedicles

Secondary

Measure	Time frame	Description
quantification of microvascular flow for each tumor	Visite 2 2weeks after Day 0	Presence or absence of arteriovenous shunts

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026