AI for precise MRI diagnosis of cranial conditions
Construction of AI Model for Precision Imaging Diagnosis of Cranial Diseases
This project will test whether an AI system can read cranial MRI scans and help doctors diagnose brain tumors, stroke, and other cranial diseases more accurately and consistently.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07446842 on ClinicalTrials.gov |
What this trial studies
The study will develop and validate an AI diagnostic model by combining cranial MRI sequences (T1, T2, FLAIR, DWI) with clinical information and structured clinical knowledge (pathophysiological classification, age stratification, anatomical localization) to simulate radiologists' diagnostic reasoning. It will use retrospective imaging and clinical data from 2015–2025 and collect prospective data in 2026 at Tongji Hospital to train and validate the model. Performance will be measured using accuracy, sensitivity, specificity and compared in clinical efficacy tests (doctor versus model and doctor with versus without model assistance) across different hospital levels and physician qualifications. The project aims to create a reproducible implementation pathway for clinical AI in cranial imaging.
Who should consider this trial
Good fit: Patients diagnosed with one of the listed cranial conditions who have standard cranial MRI scans (T1, T2, FLAIR, DWI) and available clinical records are ideal candidates.
Not a fit: Patients without the required MRI sequences or clinical data, those whose condition is not among the specified 48 diagnoses, or those with poor-quality scans are unlikely to benefit from the model.
Why it matters
Potential benefit: If successful, the AI could help doctors make faster, more accurate, and more consistent MRI-based diagnoses across hospitals, potentially reducing misdiagnoses and variation in care.
How similar studies have performed: Similar AI approaches for brain MRI have shown promising accuracy in research settings, but few have yet proven consistent clinical benefit across diverse hospitals and clinician experience levels.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.