Spatiotemporal Dynamics and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network

NCT07203495 | Active Not Recruiting

• 1 other identifier: 2025-KY-1046
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.the dynamic metabolic alterations of specific brain regions,
2. 2.the spatiotemporal associations between cerebral metabolism and systemic disease progression,
3. 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.

Conditions

Lung Diseases; Endocrine Diseases; Gastrointestinal Diseases

Keywords

18F-FDG PET; Brain-organ axis; Neuro-metabolic network

Outcome Measures

Primary Outcomes (1)

• tumor recurrence, metastasis, and death

  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.

  June 1, 2025 to September 1, 2028

Study Arms (2)

Control Group

Individuals aged 18-75 years who, based on medical history, physical examination, laboratory testing, and imaging assessments, are confirmed to be free of target diseases and related complications. This group may include healthy volunteers or individuals recruited from health check-up populations.

Disease Group

Patients aged 18-75 years with a confirmed diagnosis of lung, gastrointestinal, or endocrine diseases. Participants with organic brain lesions (e.g., stroke, Alzheimer's disease, Parkinson's disease) or psychiatric disorders (e.g., depression, anxiety, schizophrenia), or other conditions that may affect cerebral metabolism or prognosis, will be excluded.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of two groups: a healthy control group and a disease group. Healthy Control Group: Healthy volunteers or individuals recruited from health check-up populations, aged 18-75 years, who are confirmed through medical history, physical examination, laboratory tests, and imaging evaluations to be free of the target diseases and related complications. Disease Group: Patients aged 18-75 years with a confirmed diagnosis of lung, gastrointestinal, or endocrine diseases. Participants will be excluded if they present with organic brain lesions detected on imaging (including but not limited to stroke, Alzheimer's disease, or Parkinson's disease), have a history of psychiatric disorders such as depression, anxiety, or schizophrenia, or have other conditions that may interfere with cerebral metabolic imaging or influence prognosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Related Publications (4)

• Valenza G, Matic Z, Catrambone V. The brain-heart axis: integrative cooperation of neural, mechanical and biochemical pathways. Nat Rev Cardiol. 2025 Aug;22(8):537-550. doi: 10.1038/s41569-025-01140-3. Epub 2025 Mar 3.

  PMID: 40033035 BACKGROUND

• Zhong T, Duan Y, Li K, Qiu J, Cheng Z, Lu W. Directional interactions from non-small cell lung cancer to brain glucose metabolism revealed by total-body PET imaging. Eur J Nucl Med Mol Imaging. 2025 Oct;52(12):4467-4476. doi: 10.1007/s00259-025-07324-w. Epub 2025 May 9.

  PMID: 40342105 BACKGROUND

• Tricarico P, Chardin D, Martin N, Contu S, Hugonnet F, Otto J, Humbert O. Total metabolic tumor volume on 18F-FDG PET/CT is a game-changer for patients with metastatic lung cancer treated with immunotherapy. J Immunother Cancer. 2024 Apr 22;12(4):e007628. doi: 10.1136/jitc-2023-007628.

  PMID: 38649279 BACKGROUND

• Eze C, Schmidt-Hegemann NS, Sawicki LM, Kirchner J, Roengvoraphoj O, Kasmann L, Mittlmeier LM, Kunz WG, Tufman A, Dinkel J, Ricke J, Belka C, Manapov F, Unterrainer M. PET/CT imaging for evaluation of multimodal treatment efficacy and toxicity in advanced NSCLC-current state and future directions. Eur J Nucl Med Mol Imaging. 2021 Nov;48(12):3975-3989. doi: 10.1007/s00259-021-05211-8. Epub 2021 Mar 24.

  PMID: 33760957 BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Endocrine System Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)