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Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Ocular Tumor

Treatments

Diagnostic Test: Doppler technology

Study type

Interventional

Funder types

Other

Identifiers

NCT05051384
2021-A01289-32 (Other Identifier)
20-AOIP-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Intraocular tumor
Experimental group
Description:
New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors
Treatment:
Diagnostic Test: Doppler technology

Trial contacts and locations

1

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Central trial contact

Marion CAUSERET

Data sourced from clinicaltrials.gov

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