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临床试验/NCT07617038
NCT07617038Enrolling By Invitation不适用

Dynamic Oxygen-Enhanced (OE) MRI to Predict Treatment Response After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients

Université de Montréal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月27日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1

研究概览

简要总结

To predict response of HCC to TACE using dynamic oxygen-enhanced (dOE)-MRI for assessment of the level of tumor hypoxia before and after treatment.

详细描述

This will be a single-center, prospective, study to evaluate dOE-MRI in patients undergoing TACE for HCC according to the clinical standard of care. This protocol has already been approved by the local research ethics committee. Adult patients with HCC >25mm undergoing TACE are enrolled. Imaging will be performed on a 3T whole-body MRI, dOE-MRI will be acquired with a free-breathing T1-weighted dynamic acquisition with respiratory motion-resolved compressed sensing reconstruction (XD-GRASP). Tumor hypoxia will be assessed by measuring changes in the longitudinal relaxation rate (∆R1) from baseline (21% O2) and during a hyperoxic respiratory challenge (FiO2 100%). Tumor response will be assessed by mRECIST and LI-RADS Treatment Response Assessment v2024. Descriptive statistics for the level of ∆R1 pre- and post- treatment will be presented using means and standard deviations. Progression-free survival and overall survival will be evaluated by using the Cox proportional hazard model and Kaplan-Meier method. Receiver operating characteristic (ROC) curve analysis at one year will be performed and the optimal cutoff threshold of ∆R1 will be calculated using Youden's index.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no pulmonary disease
  • able to stay 2 hours in MRI

排除标准

  • contraindication for MRI
  • contraindication for contrast injection
  • claustrophobia

研究者

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

Audrey Fohlen

Principal investigator, MD, PhD

Centre hospitalier de l'Université de Montréal (CHUM)

研究点 (1)

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