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Active, Not Recruiting

NCT Number: NCT05051384

Superb Microvascular Intraocular Tumor Imaging Study (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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ocular Tumor Eye Diseases Eye Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France, 06000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler technology

Diagnostic 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

Primary outcomes

  1. Qualitative description of the intratumoral microvascular flow

    Time frame: Visite 2 - two weeks after Day 0

    Number of visible feeding pedicles

  2. Qualitative description of the intratumoral microvascular flow

    Time frame: Month 6

    Number of visible feeding pedicles

Secondary outcomes

  1. quantification of microvascular flow for each tumor

    Time frame: Visite 2 2weeks after Day 0

    Presence or absence of arteriovenous shunts

  2. quantification of microvascular flow for each tumor

    Time frame: month 6

    Presence or absence of arteriovenous shunts

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: SMITIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Sep 21, 2021
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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