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

NCT ID: NCT07203495

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

To characterize the dynamic cerebral metabolic alterations in patients with lung, gastrointestinal, or endocrine diseases.

To explore the spatiotemporal associations between specific brain region metabolism and disease progression.

To assess the prognostic value of cerebral metabolic parameters for clinical outcomes.

Primary Outcomes:

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Diseases Endocrine Diseases Gastrointestinal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

yujie bai

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 40033035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40342105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38649279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33760957 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-KY-1046

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.