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临床试验/NCT02733887
NCT02733887Unknown不适用

Research on the Lymphoma Staging and Therapeutic Evaluation of 18F-FDG PET/CT Comparing With Whole Body MRI IVIM Functional Imaging

Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年2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
66
试验地点
1
主要终点
18F-FDG uptake in lymphomas with PET/CT

研究概览

简要总结

The lymph nodes or masses,positron emission tomography/computed tomography (PET/CT) standardized uptake values(SUV) results, whole body magnetic resonance imaging(MRI) intravoxel incoherent motion(IVIM) sequence D, D*, f values and MRI volumes of lymphoma patients were compared before and after the chemotherapy in this project prospectively to provide data for evaluating the dependency and differences of PET/CT and whole body MRI in lymphoma staging and therapeutic evaluation. Long-term therapeutic effect indexes obtained in follow-up visits of patients such as Overall Survival(OS), Progression Free Survival (PFS) etc. were used to evaluate the diagnostic sensitivity and differences of MRI and PET/CT. The research could provide a new method of nonionizing radiation iconography for physicians to give appropriate treatments and predict prognosis.

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
8 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lymphoma subtypes were diagnosed on the basis of tissue samples obtained by biopsy or surgery according to the criteria outlined in the current World Health Organization (WHO) classification of hematologic and lymphoid malignancies, by a reference pathologist.
  • Patients who gave written informed consent were referred for DWI-MRI and 18F-FDG-PET/CT.
  • Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging).

排除标准

  • Pregnancy, general contraindications to MRI, and therapeutic interventions between DWI-MRI and 18F-FDG-PET/CT were used.

结局指标

主要结局

18F-FDG uptake in lymphomas with PET/CT

时间窗: Within 30 days prior to start of chemotherapy

Different 18F-FDG uptake values in lymphoma tissue (e.g. SUVmax, SUVmean, binding potential) will be measured and correlated with immunohistochemically determined somatostatin receptor status, lymphoma aggressiveness and tissue biomarkers

Agreement between DWI-MRI and 18F-FDG PET/CT at diagnosis

时间窗: Within 30 days prior to start of chemotherapy

Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT at diagnosis.

Agreement between DWI-MRI and 18F-FDG PET/CT in follow-up examinations

时间窗: 2 weeks after the 4th cycle of chemotherapy

Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT after completion of chemotherapy for treatment response assessment

次要结局

  • Progression Free Survival(6 months)
  • Overall Survival(12 months)

研究者

发起方
Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chengcheng Liao

Director, Principal Investigator, Clinical Professor

Guangxi Medical University

研究点 (1)

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