NCT05051384

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2026

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

August 20, 2021

Last Update Submit

November 25, 2025

Conditions

Ocular Tumor

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • quantification of microvascular flow for each tumor

    Visite 2 2weeks after Day 0

  • quantification of microvascular flow for each tumor

    month 6

Study Arms (1)

Intraocular tumor

EXPERIMENTAL

New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors

Diagnostic Test: Doppler technology

Interventions

Doppler technologyDIAGNOSTIC_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

Intraocular tumor

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Intraocular tumor not previously treated with proton therapy

You may not qualify if:

  • Severe active ocular, periocular or intraocular inflammation
  • Intraocular pressure \> 30 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

MeSH Terms

Conditions

Eye Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEye Diseases

Study Officials

  • Sacha NAHON ESTEVE

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 21, 2021

Study Start

April 27, 2022

Primary Completion

April 27, 2023

Study Completion

January 18, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)