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临床试验/NCT04614896
NCT04614896已完成不适用

Use of Transoral Ultrasound for Measuring Depth Of Invasion in Oral Tongue Carcinoma, and Comparing Obtained Measurements With Measurements From MRI With the Results Obtained From Pathological Examination of Surgically Resected Specimens

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Correlation of DOI measured on ultrasound and on MRI compared to pathological examination

研究概览

简要总结

The purpose of this study is to investigate the use intraoral ultrasound for measuring depth of invasion (DOI) in oral tongue squamous cell carcinoma. The DOI's measured on ultrasound and measurements from MRI scans, will be compared to the measurements made from pathological examination of removed specimens.

详细描述

The investigators will conduct a prospective cohort study to investigate the correlation between DOI measurements from preoperative imaging (MRI and intraoral ultrasound), and final histopathology findings.

All patients with oral tongue cancer histologically verified on biopsy diagnosed in the Capital Region and Zealand Region (population 2.6 mio) are treated at the department of Head and Neck surgery at Copenhagen University Hospital (Rigshospitalet). These patients will be invited to participate in the study before or at their multidisciplinary team (MDT) conference at Rigshospitalet where the final treatment will be decided.

The ultrasound exam is conducted with a bk5000 or bk3000 machine, a "Hockey Stick" X18L5s transducer or a 18L5s Linear transducer.

The transducer will be placed directly on the tongue tumor. The tumor size will be measured, and depth of invasion will be estimated. For later reevaluation of the ultrasound images, a sweep will be performed, and image files and video clips will be stored for documentation.

Patients will primarily be examined in the outpatient clinic, and the measurement will be repeated at the time of surgery when the patient is in general anesthesia. It is, however, at time of the examination outpatient clinic that the information about DOI is most useful in planning the treatment, and therefore this is measurement the investigators will be focusing on.

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

  • Patients with squamous cell carcinoma on the lateral tongue

排除标准

  • Patients with tumor elsewhere in the oral cavity

结局指标

主要结局

Correlation of DOI measured on ultrasound and on MRI compared to pathological examination

时间窗: when pathological examination is made, within 4 weeks of US and MRi

Measurement of DOI in millimeters

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

Mikkel Kaltoft

Consultant

Rigshospitalet, Denmark

研究点 (2)

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