Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-28 @ 6:09 AM
Study NCT ID:
NCT07203495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spatiotemporal Dynamics and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tumor recurrence, metastasis, and death', 'timeFrame': 'June 1, 2025 to September 1, 2028', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-FDG PET', 'Brain-organ axis', 'Neuro-metabolic network'], 'conditions': ['Lung Diseases', 'Endocrine Diseases', 'Gastrointestinal Diseases']}, 'referencesModule': {'references': [{'pmid': '40033035', 'type': 'BACKGROUND', 'citation': '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': '40342105', 'type': 'BACKGROUND', 'citation': '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': '38649279', 'type': 'BACKGROUND', 'citation': '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': '33760957', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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 :\n\n1. the dynamic metabolic alterations of specific brain regions,\n2. the spatiotemporal associations between cerebral metabolism and systemic disease progression,\n3. 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.', 'detailedDescription': "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.\n\nDespite these advances, three major limitations remain:\n\n1. most studies focus on single organ axes, lacking integrative dynamic network analyses across multiple axes;\n2. conventional static SUV metrics cannot capture the spatiotemporal evolution of metabolic pathways, while advanced dynamic PET approaches remain underutilized in clinical practice;\n3. 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.\n\nTherefore, 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.\n\nObjectives:\n\nTo characterize the dynamic cerebral metabolic alterations in patients with lung, gastrointestinal, or endocrine diseases.\n\nTo explore the spatiotemporal associations between specific brain region metabolism and disease progression.\n\nTo assess the prognostic value of cerebral metabolic parameters for clinical outcomes.\n\nPrimary Outcomes:\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will consist of two groups: a healthy control group and a disease group.\n\nHealthy 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.\n\nDisease Group: Patients aged 18-75 years with a confirmed diagnosis of lung, gastrointestinal, or endocrine diseases.\n\nParticipants 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.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy 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.\n\nDisease Group: Patients aged 18-75 years with a confirmed diagnosis of lung, gastrointestinal, or endocrine diseases.\n\nExclusion Criteria:\n\nPresence of organic brain lesions identified on imaging, including but not limited to stroke, Alzheimer's disease (AD), or Parkinson's disease (PD).\n\nHistory of psychiatric disorders such as depression, anxiety, or schizophrenia, or other conditions that may affect cerebral metabolic imaging or prognosis."}, 'identificationModule': {'nctId': 'NCT07203495', 'briefTitle': 'Spatiotemporal Dynamics and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'An Observational Clinical Study on the Spatiotemporal Changes and Prognostic Value of the 18F-FDG PET Neuro-Metabolic Network', 'orgStudyIdInfo': {'id': '2025-KY-1046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': '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.'}, {'label': 'Disease Group', 'description': "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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The following de-identified individual participant data (IPD) will be shared:\n\nClinical data: demographics, diagnosis, medical history, laboratory results, follow-up information, and outcome events (tumor recurrence, metastasis, death).\n\nImaging-derived data: quantitative 18F-FDG PET parameters (e.g., SUV values, metabolic tumor volume \\[MTV\\], kinetic parameters, connectivity measures).\n\nProcessed imaging files: de-identified parametric maps and derived neuro-metabolic connectivity matrices.\n\nSupporting documents: study protocol, data dictionary, and analysis code used for image preprocessing and statistical modeling.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'yujie bai', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}