跳至主要内容
临床试验/NCT04334720
NCT04334720Unknown不适用

PET/MRI Study on the Effects of Psychosocial on Fat and Muscle Metabolism for Malignant Tumor Patient After Comprehensive Treatment.

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年7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
300
试验地点
1
主要终点
Change of activated M&F volume

研究概览

简要总结

False positives for Brown Fat & Muscle(F&M) always affect the evaluation of metabolic disease treatment. Recently, using PET/CT,international journals such as Journal of Nuclear Medicine reported that the amount of active brown fat was correlated with renal creatinine clearance and subject to regulation by atrial natriuretic peptide in addition to association of season and temperature. At present,studies based on PET/CT have shown that elimination of the above factors, brown fat(even muscle) will still appear false positive metabolism in tumor patients. In view of the basis of Positron emission computed tomography/Magnetic resonance (PET/MRI) brain function research,our team speculate that it may be related to psychological or cortex metabolism. And there is a lack of studies on the correlation between the psychosocial,cortex structure and metabolism. Therefore, it suggests that,combination of structure and metabolism,PET/MRI will play a role in studying the effects of psychological on F&M false-positive metabolism in malignant patients. In this project, the investigators intend to observe the changes of F&M metabolism with psychological and cortex metabolism after comprehensive treatment in malignant patient by combining PET/MRI. The relationship between F&M metabolism and psychological will be deeply analyzed to provide scientific basis for the development of the differential diagnosis and assessment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of malignant tumor
  • Have not yet been receiving comprehensive treatment and should begin within one month
  • Fasting glucose of diabetic patients is controlled below 11.1 mmol/L.
  • Inclusion Criteria for Healthy Control Participants:
  • Clinical diagnosis of Healthy Control

排除标准

  • Fasting glucose ≥11.1mmol/L
  • History of endocrine disease (such as chronic glomerulonephritis, Addison's disease)
  • Neurological signs and/or history of neurological disease
  • Have begun comprehensive treatment
  • Presence of magnetically active objects in the body
  • Claustrophobia or any other medical condition that would preclude the participant from lying in the PET/MRI scanner for approximately 40 mins.

结局指标

主要结局

Change of activated M&F volume

时间窗: Baseline, 1 day ( Contrast scanning)

Activated M\&F volume before and after comprehensive treatment were evaluated by post-processing software

Change of M&F SUVmax and SUVmean

时间窗: Baseline, 1 day ( Contrast scanning)

SUVmax and SUVmean scores will be measured by post-processing software.

Change of anxiety symptoms

时间窗: Baseline, 1 day ( Contrast scanning)

Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale.

Change metabolism of glucose of M&F

时间窗: Baseline, 1 day ( Contrast scanning)

Glucose metabolic scores will be assessed with visual scale

Change of metabolism of glucose in the M&F

时间窗: Baseline, 1 day ( Contrast scanning)

Accumulation of 18F-FDG will be analyzed by treatment-related, psychology-related and intervention-related Positron emission tomography/ Magnetic resonance

Change of the glucose metabolism area of M&F

时间窗: Baseline, 1 day ( Contrast scanning)

Five different anatomical locations (subphrenic, paravertebral, mediastinal, cervical, supraclavicular) will be assessed with visual.

Change of sleep

时间窗: Baseline, 1 day ( Contrast scanning)

Sleep scores will be assessed with Pittsburgh sleep quality index one month before scanning

次要结局

未报告次要终点

研究者

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

研究点 (1)

Loading locations...

相似试验