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| ID | Type | Description | Link |
|---|---|---|---|
| TJ-IRB202601011 | Other Identifier | Tongji Hospital |
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The goal of this observational study is to develop and validate a high-precision AI diagnostic model for cranial diseases by integrating clinical knowledge systems (pathophysiological classification, age stratification, and anatomical localization) to simulate radiologists' diagnostic thinking. The main question it aims to answer is: Does the AI model improve diagnostic accuracy and consistency across different hospital levels, physician qualifications, and clinical scenarios compared to traditional diagnosis? Participants' cranial MRI data (including T1, T2, FLAIR, DWI sequences) and clinical information will be collected retrospectively (2015-2025) and prospectively (2026) to train and validate the model, which will be evaluated through performance metrics (accuracy, sensitivity, specificity) and clinical efficacy assessments (doctor vs. model, with/without model assistance). This study will establish a new paradigm for clinical AI implementation, providing methodological support for precision diagnosis of neurological diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective data collection from January 1, 2015 to December 31, 2025, including 70,000 subjects | including 70,000 unsupervised training cases and 2,000 supervised training cases for model development. | ||
| Prospective Cohort | Prospective data collection from March 1, 2026 to December 31, 2026, including 1,000 cases for model validation and clinical efficacy evaluation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of AI model (sensitivity, specificity, AUC) | The primary outcome is the diagnostic performance of the AI model, including sensitivity, specificity, and area under the ROC curve (AUC), compared to the gold standard (e.g., histopathology or clinical diagnosis). | Within 1 month of image acquisition |
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Inclusion Criteria:
Patients clinically diagnosed with one of the following 48 cranial diseases: glioma, lymphoma, meningioma, pituitary macroadenoma, ependymoma, choroid plexus papilloma, schwannoma, medulloblastoma, metastatic tumor, chordoma, craniopharyngioma, germinoma, hemangioblastoma, cholesteatoma, teratoma, viral encephalitis, brain abscess, cerebral tuberculosis infection, cryptococcal encephalitis, cerebral cysticercosis, general soft meningitis (including bacterial, fungal infections, and autoimmune meningitis), tuberculous meningitis, ischemic stroke, cerebral venous sinus thrombosis, arteriovenous malformation, cavernous hemangioma, venous developmental malformation, aneurysm, cerebral small vessel disease, epidural hemorrhage, subdural hemorrhage, intracerebral hemorrhage, cerebral contusion, subarachnoid hemorrhage, diffuse axonal injury, multiple sclerosis, hippocampal sclerosis, focal cortical dysplasia, cortical or cerebral fissure malformations, basilar invagination, Chiari malformation, Dandy-Walker malformation, Rathke's cleft cyst, pituitary hypoplasia, adrenoleukodystrophy, Alzheimer's disease, Parkinson's disease, arachnoid cyst.
Exclusion Criteria:
Patients with other severe neurological diseases not included in the 48 specified cranial diseases; Patients unable to provide complete cranial imaging data (e.g., missing images or images of poor quality); Patients with severe cognitive impairment unable to cooperate with the study (e.g., unable to understand study procedures or communicate with site personnel); Pregnant or lactating women; Patients with severe dysfunction of major organs (e.g., heart, liver, kidney) that cannot tolerate study-related examinations; Patients who refuse to sign the informed consent form.
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The study population will consist of patients diagnosed with the 48 specified cranial diseases from various hospitals, including neurology departments of tertiary hospitals, specialized clinics, and community medical centers. Participants will be selected based on clinical diagnosis and availability of complete cranial imaging data, ensuring representation of diverse disease types and severities for model training and validation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D020521 | Stroke |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |