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临床试验/NCT07203495
NCT07203495进行中(未招募)不适用

An Observational Clinical Study on the Spatiotemporal Changes and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network

The First Affiliated Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
tumor recurrence, metastasis, and death

研究概览

简要总结

This observational clinical study aims to investigate the spatiotemporal changes of the 18F-FDG PET neuro-metabolic network in patients with lung, gastrointestinal, or endocrine diseases. The study seeks to clarify :

  1. the dynamic metabolic alterations of specific brain regions,
  2. the spatiotemporal associations between cerebral metabolism and systemic disease progression,
  3. the prognostic value of neuro-metabolic parameters. Participants will undergo 18F-FDG PET/CT imaging, clinical assessments, and longitudinal follow-up to evaluate outcomes such as tumor recurrence, metastasis, and survival.

详细描述

The brain-organ axis, including the brain-lung, brain-heart, brain-gut, and brain-endocrine pathways, has emerged as a critical research field for systemic disease pathophysiology. 18F-FDG PET/CT provides a unique noninvasive tool to quantify neural metabolic activity and to reveal central-peripheral interactions in cross-axis disorders. Previous studies have demonstrated that chronic hypoxia in lung diseases can lead to global cerebral metabolic suppression, with prominent hypometabolism in the frontal cortex and hippocampus, directly correlating with cognitive decline. Similarly, brain-heart axis dysfunction in heart failure is characterized by hypothalamic-amygdala hypermetabolism and hippocampal hypometabolism, linked to higher rehospitalization risk. Inflammatory bowel disease demonstrates abnormal hypermetabolism in the insula and anterior cingulate cortex, correlated with intestinal mucosal damage. Moreover, 18F-FDG PET can sensitively detect pituitary microadenomas and predict postoperative recurrence in Cushing's disease.

Despite these advances, three major limitations remain:

  1. most studies focus on single organ axes, lacking integrative dynamic network analyses across multiple axes;
  2. conventional static SUV metrics cannot capture the spatiotemporal evolution of metabolic pathways, while advanced dynamic PET approaches remain underutilized in clinical practice;
  3. prognostic models often rely on single-modality parameters, ignoring the added value of multimodal integration, as shown by recent evidence combining DWI-derived ADC values with PET metabolic parameters to enhance prognostic accuracy in NSCLC.

Therefore, this prospective cohort study will systematically map neuro-metabolic remodeling patterns of brain-organ axis diseases using 18F-FDG PET imaging, and establish metabolism-based prognostic stratification models.

Objectives:

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Control Group: Healthy volunteers or individuals from health check-up populations who, based on medical history, physical examination, laboratory testing, and imaging assessments, are confirmed to be free of target diseases and related complications.
  • Disease Group: Patients aged 18-75 years with a confirmed diagnosis of lung, gastrointestinal, or endocrine diseases.

排除标准

  • Presence of organic brain lesions identified on imaging, including but not limited to stroke, Alzheimer's disease (AD), or Parkinson's disease (PD).
  • History of psychiatric disorders such as depression, anxiety, or schizophrenia, or other conditions that may affect cerebral metabolic imaging or prognosis.

结局指标

主要结局

tumor recurrence, metastasis, and death

时间窗: June 1, 2025 to September 1, 2028

The primary outcomes include tumor recurrence, metastasis, and death. All events will be adjudicated by at least two independent clinicians based on comprehensive clinical information and professional expertise. The number and timing of outcome events will be recorded at the end of follow-up for each participant.

次要结局

未报告次要终点

研究者

发起方
The First Affiliated Hospital of Zhengzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

yujie bai

Attending Physician

The First Affiliated Hospital of Zhengzhou University

研究点 (1)

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