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

Primary Purpose

Ocular Tumor

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Doppler technology
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ocular Tumor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CAUSERET Marion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraocular tumor

Arm Description

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

Outcomes

Primary Outcome Measures

Qualitative description of the intratumoral microvascular flow
Number of visible feeding pedicles
Qualitative description of the intratumoral microvascular flow
Number of visible feeding pedicles

Secondary Outcome Measures

quantification of microvascular flow for each tumor
Presence or absence of arteriovenous shunts
quantification of microvascular flow for each tumor
Presence or absence of arteriovenous shunts

Full Information

First Posted
August 20, 2021
Last Updated
September 10, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05051384
Brief Title
Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)
Acronym
SMITIS
Official Title
Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2021 (Anticipated)
Primary Completion Date
September 17, 2022 (Anticipated)
Study Completion Date
September 17, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraocular tumor
Arm Type
Experimental
Arm Description
New sonographic software technique on ultrasonography to detect low-vascular flow inside intraocular tumors
Intervention Type
Diagnostic Test
Intervention Name(s)
Doppler technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Qualitative description of the intratumoral microvascular flow
Description
Number of visible feeding pedicles
Time Frame
Visite 2 - two weeks after Day 0
Title
Qualitative description of the intratumoral microvascular flow
Description
Number of visible feeding pedicles
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
quantification of microvascular flow for each tumor
Description
Presence or absence of arteriovenous shunts
Time Frame
Visite 2 2weeks after Day 0
Title
quantification of microvascular flow for each tumor
Description
Presence or absence of arteriovenous shunts
Time Frame
month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion CAUSERET
Phone
0492034702
Email
causeret.m@chu-nice.fr
Facility Information:
Facility Name
CAUSERET Marion
City
Nice
State/Province
Chu de Nice
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAUSERET Marion
Phone
0492034702
Email
causeret.m@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
NAON-ESTEVE sacha, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)

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