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临床试验/NCT06336941
NCT06336941招募中不适用

Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions

University of Pisa1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Depth of invasion

研究概览

简要总结

Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.

In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of oral squamous cell carcinoma
  • Eligibility for surgical treatment
  • Acceptance to be included in the study

排除标准

  • Oral lesions other than oral squamous cell carcinoma
  • Pregnant or breastfeeding patients
  • Uncontrolled chronic diseases and/or conditions hindering the participation in the study
  • Denial of inclusion in the study

研究组 & 干预措施

Ultrasound group

Experimental

The patients with a clinical diagnosis of oral squamous cell carcinoma will undergo intraoral ultrasonographic scan with a 70 MHz frequency probe to evaluate tumor depth of invasion and thickness

干预措施: Ultrasound (Device)

结局指标

主要结局

Depth of invasion

时间窗: measured preoperatively

Measurement of Depth of invasion on ultrasonography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rossana Izzetti

Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

University of Pisa

研究点 (1)

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