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临床试验/NCT06314711
NCT06314711已完成不适用

Tumor Volume and Margin Assessment With ex Vivo 3D-ultrasound After Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Blind-assessed tumor size from fresh ex vivo US

研究概览

简要总结

Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).

Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.

The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment.

详细描述

The purpose of the study is to determine the accuracy of ex vivo 3D ultrasound (US) for detecting and delineating tumor tissue of the tonsils and base of tongue post-operatively. This is a quick technique that may provide valuable information for the surgeon that can potentially improve treatment outcomes.

Placing the surgical specimen in a water bath allows for an US swipe to be performed without compressing the specimen. This reduces the deformation of the specimen by removing the pressure from conventional US scanning. A video clip can be captured by swiping across the specimen in the water bath. By motorizing this motion, the video can be converted into a 3D volume due to the known number of video frames and a constant swiping speed.

We will correlate the ex vivo 3D US scans to histopathology for the following analyses:

  • Four surgeons blinded to histopathology will rate each included case in terms of tumor visibility on ex vivo 3D US scans. If visible, the surgeons will mark the tumor and the healthy tissue.
  • Tumor and margins will be correlated to histopathology pre- and post-formalin fixation on a subset of cases to explore the proportion of tissue shrinkage from formalin fixation.
  • Two methods of estimating tumor volume will be compared: the ellipsoidal formula and full 3D segmentation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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 surgically treated with transoral robotic surgery for oropharyngeal squamous cell carcinoma or HPV-positive unknown primary.

排除标准

  • No primary tumor found on final histopathology.

研究组 & 干预措施

Post-operative ex vivo 3D ultrasound

Experimental

3D ultrasound of surgical specimen

干预措施: Ultrasound (Diagnostic Test)

结局指标

主要结局

Blind-assessed tumor size from fresh ex vivo US

时间窗: day 1

Tumor width and thickness (mm) estimated by blinded perioperative ex vivo 3D-US

Blind-assessed deep and lateral margin measurements on fresh ex vivo US

时间窗: day 1

Deep and lateral margin measurements (mm) by blinded perioperative ex vivo 3D-US.

次要结局

  • Margin involvement (categorical)(day 1)
  • Fresh vs formalin-fixed ex vivo US tumor volume(day 1)

研究者

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

Martin Garset-Zamani, MD

Principal Investigator

Rigshospitalet, Denmark

研究点 (2)

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DRKS00028010niversitätsmedizin Göttingen