Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

Ocular Tumor Clinical Trial

— SMITIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05051384
• Other study ID #: 20-AOIP-05
• Secondary ID: 2021-A01289-32
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: September 17, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 17, 2024
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Neoplasms
• Ocular Tumor

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative description of the intratumoral microvascular flow	Number of visible feeding pedicles	Visite 2 - two weeks after Day 0
Primary	Qualitative description of the intratumoral microvascular flow	Number of visible feeding pedicles	Month 6
Secondary	quantification of microvascular flow for each tumor	Presence or absence of arteriovenous shunts	Visite 2 2weeks after Day 0
Secondary	quantification of microvascular flow for each tumor	Presence or absence of arteriovenous shunts	month 6