跳至主要内容
临床试验/NCT05051384
NCT05051384进行中(未招募)不适用

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

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
22
试验地点
2
主要终点
Qualitative description of the intratumoral microvascular flow

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Qualitative description of the intratumoral microvascular flow

时间窗: Month 6

Number of visible feeding pedicles

次要结局

  • quantification of microvascular flow for each tumor(month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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