跳至主要内容
临床试验/NCT03991533
NCT03991533已完成不适用

Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer

AZ Sint-Jan AV0 个研究点目标入组 30 人开始时间: 2016年11月1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
主要终点
discriminatory value of MRI D-value

研究概览

简要总结

The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

详细描述

Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.

Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.

Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').

Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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 that received a pretreatment multiparametric MRI according to a standardized protocol between December 2016 and December 2018
  • histophatologically proven SCC in the head and neck region
  • one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report

排除标准

  • patients not fulfilling abovementioned criteria
  • patients with thyroid or skin cancer
  • considerable artefact on MRI
  • previous surgery, irradiation or chemotherapy in the HN region

结局指标

主要结局

discriminatory value of MRI D-value

时间窗: preoperative

differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'

discriminatory value of MRI perfusion curve

时间窗: preoperative

differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'

discriminatory value of MRI ADC

时间窗: preoperative

differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'

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

Johan Abeloos

Principal investigator

AZ Sint-Jan AV

相似试验

Use of Multiparametric MRI in the Management of Head... | 临床试验