PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients
研究概览
简要总结
This study intends to evaluate the application value of Positron Emission Tomography/Magnetic Resonance (PET/MR) in the staging and efficacy evaluation of NK/T cell lymphoma, aiming to explore a more accurate system for predicting the prognosis of patients and guiding the treatment.
详细描述
Nature Killer/T-cell Lymphoma (NKTCL) is a highly heterogeneous, aggressive lymphoma subtype with poor prognosis. Ninty percent of patients have lesions involving the nasal region, other extranodal organs include adrenal glands, gastrointestinal tract, skin and so on. Local tumor infiltration (bone, skin, paranasal sinus, etc) is a poor prognostic factor. Therefore, NK/T-cell lymphomas have high demands on the resolution of fine anatomical structures. PET/CT and nasopharyngeal contrast-enhanced MR are routine examination methods for diagnostic staging and efficacy evaluation, but the images cannot be fused, and the divided examinations bring inconvenience to patients.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed NK/T-cell lymphoma based on the WHO classification 2016
- •Age from 14 to 70 years-old
- •ECOG 0-2 score
- •Patients with a life expectancy of at least 6 months
- •Patient has not been treated before for NK/T cell lymphoma
- •Commit to abide by the research procedures and cooperate with the implementation of the whole process of research
- •Written informed consent
排除标准
- •Subjects who meet any of the following criteria are not eligible for study entry
- •Diagnosed aggressive NK cell leukemia
- •Pregnant or lactating women
- •Liver and kidney insufficiency
- •Other PET/MR contraindications:
- •Those with implanted functional electronic devices such as cardiac pacemakers
- •Carotid aneurysm clipping and other implants are ferromagnetic materials
- •Implanted perfusion devices such as insulin perfusion pumps
- •Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients
- •Those who are claustrophobic
- •Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study
结局指标
主要结局
The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients
时间窗: Baseline
SUVmax, organs, et al.
The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patients
时间窗: After at least 2 cycles
SUVmax, organs, et al.
次要结局
- Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators.(Baseline up to data cut-off (up to approximately 4 years))
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital