Superb Microvascular Intraocular Tumor Imaging Study (SMITIS) (SMITIS)

November 25, 2025 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Nice, France, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraocular tumor
New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors
Diagnostic test: Doppler 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Sacha NAHON ESTEVE, Centre Hospitalier Universitaire De Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

April 27, 2023

Study Completion (Estimated)

January 18, 2026

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-AOIP-05
  • 2021-A01289-32 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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