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临床试验/NCT05843032
NCT05843032尚未招募不适用

3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Clinical Evaluation, MRI, and Histopathology

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
27
试验地点
2
主要终点
Diagnostic accuracy - number of margins correctly classified as free (> 5 mm), close (1- 5 mm) or positive (<1 mm) margin by 3D ultrasound and MRI using histopathology findings as the reference

研究概览

简要总结

In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.

详细描述

Cancer surgery is the primary treatment in the early stages of tongue squamous cell carcinoma (SCC), and the goal is the complete resection of the tumor with an adequate margin of healthy tissue around to ensure proper cancer removal. Inadequate margins lead to a high risk of local cancer recurrence and the patient will need re-surgery or adjuvant therapies. Ex-vivo imaging of the resected surgical specimen has been suggested to provide information for margin assessment and thus improve cancer surgery. In this manuscript, a protocol to investigate the clinical benefit of three-dimensional (3D) ultrasound imaging of the surgical margins and comparing the results to magnetic resonance imaging (MRI) and the clinical examination of the surgical specimen by surgeon (palpation to inspect the resected tissue) has been designed. Tumor segmentation and margin measurement (Anterior towards apex of tongue, posterior towards base of tongue, medial towards back of tongue, lateral towards floor of mouth, and profound/deep margins) will be performed by head and neck surgeons on 3D ultrasound images and by two consultant radiologists on MRI of the ex-vivo specimen. Accuracy of each method will be evaluated by computing the proportion of correctly classified margins (positive, close, and free) by each technique with respect to the gold standard histopathology.

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 biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment
  • T1-T3 staging on cross-sectional imaging

排除标准

  • T4 staging
  • Unable to understand the verbal or written information
  • Prior radiotherapy treatment of oral cavity cancer

结局指标

主要结局

Diagnostic accuracy - number of margins correctly classified as free (> 5 mm), close (1- 5 mm) or positive (<1 mm) margin by 3D ultrasound and MRI using histopathology findings as the reference

时间窗: 2 weeks

Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens.

时间窗: 2 weeks

次要结局

  • Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)(2 weeks)
  • Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation(2 weeks)

研究者

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

Fatemeh Makouei

Biomedical Engineer, PhD, Assistant professor

Rigshospitalet, Denmark

研究点 (2)

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