跳至主要内容
临床试验/NCT03102112
NCT03102112Unknown不适用

Noninvasively Predicting Isocitrate Dehydrogenase Gene Status in Glioma by Amide Proton Transfer Imaging

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
APT image for assessing the gene alteration

研究概览

简要总结

Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical outcome of patients with glioblastoma depends on key molecular genetic alteration. Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a glioma is fundamental in order to determine the treatment strategy. Amide proton transfer (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation transfer mechanism that detects endogenous mobile proteins and peptides in biological tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve as a new imaging biomarker, by revealing significantly higher signal intensities in the high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of isocitrate dehydrogenase (IDH) gene status in glioma.

详细描述

Materials and Methods:

The whole brain MRI examinations were performed on a 3.0-T MRI system (Discovery MR750, General Electric Medical System, Milwaukee, WI, USA) with an eight-channel head coil (General Electric Medical System). Conventional MRI, contrast-enhanced MRI, DWI and amide proton transferimaging were performed in regular sequence during the same examination. Finally, contrast-enhanced T1-weighted spin echo sequence was acquired in the transverse, sagittal, and coronal planes after intravenous administration of 0.01 mmol/kg gadodiamide (Omniscan; GE Healthcare, Co. Cork, Ireland).

MRI data processing and image analysis:

All data were transferred to a workstation (Advantage Workstation 4.6, General Electric Medical System, Milwaukee, Wisconsin, USA) for processing.The MR imaging of all the patients were assessed independently by two experienced neuroradiologist (HYC and YLF, who have 12 and 6 years of experience, respectively, in neurologic-oncologic imaging) who were blinded to the patient's information. Next, a region of interest (ROI) was drawn manually on the solid part of the tumor with the relatively higher signal intensity on APT image.

Statistical analysis:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • no hypertension or cerebral vascular diseases
  • no use of corticosteroid drugs
  • no MRI contraindication
  • no allergic constitution

排除标准

  • pregnant wowan
  • motion cause poor image quality

结局指标

主要结局

APT image for assessing the gene alteration

时间窗: 15 months

Prospectively acquire the APTw signal intensity to assess the efficiency for predicting the ATRX as prognostic or predictive biomarkers of gliomasloss/mutation, 1p/19q status, IDH1/2 gene mutations and MGMT promoter methylation

次要结局

  • APT image for predicting the survival of glioma(24 months)

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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