Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05051384

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Tumor	Diagnostic Test: Doppler technology	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 17, 2021

Anticipated Primary Completion Date :

Sep 17, 2022

Anticipated Study Completion Date :

Sep 17, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Qualitative description of the intratumoral microvascular flow [Visite 2 - two weeks after Day 0]
Number of visible feeding pedicles
Qualitative description of the intratumoral microvascular flow [Month 6]
Number of visible feeding pedicles

Secondary Outcome Measures

quantification of microvascular flow for each tumor [Visite 2 2weeks after Day 0]
Presence or absence of arteriovenous shunts
quantification of microvascular flow for each tumor [month 6]
Presence or absence of arteriovenous shunts

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAUSERET Marion	Nice	Chu de Nice	France	06003

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05051384

Other Study ID Numbers:

20-AOIP-05
2021-A01289-32

First Posted:

Sep 21, 2021

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Eye Neoplasms

Study Results

No Results Posted as of Sep 21, 2021