NCT07446842 Construction of AI Model for Precision Imaging Diagnosis of Cranial Diseases
| NCT ID | NCT07446842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Cranial Diseases (e.g., Brain Tumors, Stroke, Neurodegenerative Disorders) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT07446842 clinical trial?
This trial is open to participants of all sexes, studying Cranial Diseases (e.g., Brain Tumors, Stroke, Neurodegenerative Disorders). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07446842 currently recruiting?
Yes, NCT07446842 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tongji Hospital to inquire about joining.
Where is the NCT07446842 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07446842 clinical trial?
NCT07446842 is sponsored by Tongji Hospital. The trial plans to enroll 1,000 participants.
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