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临床试验/NCT04117139
NCT04117139Unknown不适用

The Diagnostic Value of 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose-Positron-Emission-Tomography/Magnetic-Resonance Imaging (PET/MRI) for Cervical Lymph Node Metastasis in Head and Neck Squamous Cell Carcinoma

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2019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
入组人数
142
试验地点
2
主要终点
Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes

研究概览

简要总结

This study investigates the diagnostic value of PET/MRI for cervical lymph node metastases from head and neck squamous cell carcinomas.

详细描述

The Danish fast-track cancer program standardizes the work-up of patients suspected of head and neck cancer. Currently, the guidelines recommend head and neck magnetic resonance imaging (MRI) as the standard imaging modality for assessment of the primary tumor site and potential nodal metastases. However, recent studies have shown advantages in the use of 18F-FDG-PET (PET) combined with computed tomography (CT) due to its superiority in detecting metastases and synchronous cancers.

During the last couple of years PET/MRI has been introduced. MRI is known to provide the highest anatomic detail in the head and neck region, and preliminary studies show promising results. However, the evidence is still very sparse.

The purpose of the project is to investigate the diagnostic value of PET/MRI in patients with head and neck squamous cell carcinoma. The hypothesis is that PET/MRI provides a more precise diagnosis of regional lymph node metastases, and thus, make the surgical treatment of the neck more accurate and less invasive resulting in reduced morbidity.

The project is designed as a prospective cohort study based on paired data with head-to-head comparison of CT, MRI, PET/CT and PET/MRI. Patients will be included from the head and neck cancer fast-track program at the Center of Head and Neck Cancer, Odense University Hospital (OUH).

Included patients will be offered PET/MRI in addition to the conventional fast-track imaging. The description of the images will be made blinded. When a neck dissection of the lymph nodes is made, the lymph nodes will be separated in defined regions. The diagnostic accuracy of the individual imaging modalities is assessed for each neck level with histology as standard reference.

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 either suspected of or with histologically verified:
  • Relapse of head and neck squamous cell cancer with involvement of regional lymph node(s)
  • Cervical lymph node metastasis with unknown primary tumor site
  • Oral cavity squamous cell carcinoma
  • Oropharyngeal squamous cell cancer planned for trans oral robotic surgery

排除标准

  • Patients who cannot have a PET/MRI performed for different reasons (allergy, claustrophobia, medical implants)
  • Patients who had surgery, infection or other inflammatory inducing conditions on the neck within the last 8 weeks

研究组 & 干预措施

Study Group

Other

In addition to other standard imaging modalities in the fast track cancer program, included patients will have a PET/MRI done.

干预措施: PET/MRI (Diagnostic Test)

结局指标

主要结局

Diagnostic Accuracy of PET/MRI for Malignancy in Regional Lymph Nodes

时间窗: 7-10 days

PET/MRI scans are compared to histology as the golden standard to determine the diagnostic accuracy of PET/MRI for malignancy in regional lymph nodes

次要结局

  • Diagnostic Accuracy of PET/MRI for Extracapsular Lymph Node Spread(7-10 days)

研究者

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

Chadi Nimeh Abdel-Halim

Medical Doctor and Principal Investigator

Odense University Hospital

研究点 (2)

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