跳至主要内容
临床试验/NCT03429868
NCT03429868已完成不适用

Prognostic Value of the Integrated PET/MRI in Patients With Nasopharyngeal Carcinoma

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. Integrated PET/MRI is a new imaging modality, which can simultaneously acquire PET and MRI images. Considering the lack of reports on the use of hybrid PET/MRI systems in prognosis prediction in NPC, the investigators conduct this prospective study to investigate the roles of integrated PET/MRI parameters for predicting treatment outcome and prognosis in patients with NPC.

详细描述

  1. Background:

Nasopharyngeal carcinoma (NPC) has a higher local tumor control rate but a higher incidence of distant metastasis compared with squamous cell carcinomas of other regions of the head and neck. Thus, it's usually considered a distinct study group. A reliable clinical prognostic factor for NPC patients is still lacking. Positron emission tomography (PET) with 2- [fluorine- 18]fluoro-2-deoxy-D-glucose (18F-FDG)/computed tomography (CT) has been used extensively for diagnosis and assessment of prognosis in NPC in recent years. Several PET-derived imaging parameters such as standardized uptake value (SUV), metabolic tumor volume (MTV), or total lesion glycolysis (TLG) have been proposed as potential prognosticators in NPC. MRI functional parameters also play a role to assess the cellular or molecular change of head and neck cancer. Diffusion-weighted MR imaging (DWI) is a technique, which can quantify the diffusion of water molecules in tissues using apparent diffusion coefficient (ADC). ADC is inversely correlated with cellular density. Dynamic contrast-enhanced perfusion MR imaging (DCE-MRI) is another MRI technique based on sequential imaging obtained during the passage of a contrast of agent through the tissue. It enables probing the microvascular environment in the tumor tissue.

Integrated PET/MRI is a new imaging modality, which can simultaneously acquire PET and MRI images. Traditionally, PET and MRI images were acquired on different dates and were fused by commercial software. Problems caused by a separate system include SUV or MRI parameters were reported to be different if the scans were acquired on different days. Simultaneous acquisition of PET and MRI images would solve these problems. 2. Aim: The investigators conduct this prospective study to investigate the roles of integrated PET/MRI imaging parameters for predicting treatment outcomes and prognosis in patients with NPC. 3. Study design:

Patients: All patients receive whole-body 18F-FDG PET/MRI following 18F-FDG-PET/CT on the same day. For tumor staging, the 7th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) cancer staging system is used. The patients with stage I disease are treated with definitive radiation therapy alone, while patients with stage II-IVB are treated with concurrent chemoradiotherapy. Patients with metastatic disease (stage IVC) are treated with standard platinum-based chemotherapy.

18F-FDG PET/CT: All study patients fast for at least 6 h before 18F-FDG PET/CT imaging. Scans are performed using a Biograph mCT scanner (Siemens Medical Solutions, Malvern, PA, USA) consisting of a four-ring PET scanner (axial field-of-view [FOV] = 22.1 cm, transaxial FOV = 70 cm) and a 40-section CT scanner.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy proven primary nasopharyngeal carcinoma
  • Age > or = 20
  • Willing to receive therapy
  • The ability to provide written informed consent and receive the scheduled scans

排除标准

  • Woman with pregnancy or during lactation
  • A history of other malignancies or concomitant cancers in different anatomical locations
  • Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia

结局指标

主要结局

Overall survival

时间窗: 3 years

Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients.

次要结局

  • Recurrence-free survival(3 years)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验