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Construction of AI Model for Precision Imaging Diagnosis of Cranial Diseases

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
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• 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.

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov