Lung DiseasesNCT07203495
Spatiotemporal Dynamics and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network
An observational study of Lung Diseases and Endocrine Diseases, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. the dynamic metabolic alterations of specific brain regions, 2. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Endocrine Diseases, Gastrointestinal Diseases
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Dec 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: An Observational Clinical Study on the Spatiotemporal Changes and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network
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 :
- the dynamic metabolic alterations of specific brain regions,
- the spatiotemporal associations between cerebral metabolism and systemic disease progression,
- 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.
Read the detailed description
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:
- most studies focus on single organ axes, lacking integrative dynamic network analyses across multiple axes;
- conventional static SUV metrics cannot capture the spatiotemporal evolution of metabolic pathways, while advanced dynamic PET approaches remain underutilized in clinical practice;
- 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
- Lung Diseases, Endocrine Diseases, Gastrointestinal Diseases
- Keywords
- 18F-FDG PET, Brain-organ axis, Neuro-metabolic network
- Medical subject headings
- Lung Diseases, Endocrine System Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 1, 2025 to September 1, 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yujie bai, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203495
- Sponsor's protocol ID
- 2025-KY-1046
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following de-identified individual participant data (IPD) will be shared: Clinical data: demographics, diagnosis, medical history, laboratory results, follow-up information, and outcome events (tumor recurrence, metastasis, death). Imaging-derived data: quantitative 18F-FDG PET parameters (e.g., SUV values, metabolic tumor volume \[MTV\], kinetic parameters, connectivity measures). Processed imaging files: de-identified parametric maps and derived neuro-metabolic connectivity matrices. Supporting documents: study protocol, data dictionary, and analysis code used for image preprocessing and statistical modeling.
Publications
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.
PubMed 40033035Zhong 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.
PubMed 40342105Tricarico 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.
PubMed 38649279Eze 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.
PubMed 33760957
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study on the Spatiotemporal Changes and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network
- ClinicalTrials.gov ID
- NCT07203495
- Acronym / sponsor ID
- 2025-KY-1046
- Conditions
- Lung Diseases, Endocrine Diseases, Gastrointestinal Diseases
- Keywords
- 18F-FDG PET, Brain-organ axis, Neuro-metabolic network
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- the dynamic metabolic alterations of specific brain regions,
- the spatiotemporal associations between cerebral metabolism and systemic disease progression,
- 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
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:
- most studies focus on single organ axes, lacking integrative dynamic network analyses across multiple axes;
- conventional static SUV metrics cannot capture the spatiotemporal evolution of metabolic pathways, while advanced dynamic PET approaches remain underutilized in clinical practice;
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tumor recurrence, metastasis, and death
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 40033035Valenza 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.
- Background: PubMed 40342105Zhong 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.
- Background: PubMed 38649279Tricarico 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.
- Background: PubMed 33760957Eze 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.
- Individual participant dataSharing planned: Yes. The following de-identified individual participant data (IPD) will be shared: Clinical data: demographics, diagnosis, medical history, laboratory results, follow-up information, and outcome events (tumor recurrence, metastasis, death). Imaging-derived data: quantitative 18F-FDG PET parameters (e.g., SUV values, metabolic tumor volume [MTV], kinetic parameters, connectivity measures). Processed imaging files: de-identified parametric maps and derived neuro-metabolic connectivity matrices. Supporting documents: study protocol, data dictionary, and analysis code used for image preprocessing and statistical modeling.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Endocrine Diseases, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor recurrence, metastasis, and death (time frame: June 1, 2025 to September 1, 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07203495, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.