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Clinical study on the effectiveness and safety of magnetic resonance imaging assisted diagnostic software for neurological disorders in clinical application

Clinical study on the effectiveness and safety of magnetic resonance imaging assisted diagnostic software for neurological disorders in clinical application

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078680
Enrollment
Unknown
Registered
2023-12-15
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy

Interventions

Gold Standard:Gold standard expert group: composed of 3 people, including 2 film reading experts and 1 arbitration expert
Each center has one gold standard expert. Firstly, two film reading experts will review the film back-to-back, and if the results are consistent, the output will be the gold standard result
If the results are inconsistent, they shall be submitted to arbitration experts for arbitration, and the arbitration result shall be taken as the final gold standard result.
Index test:Doctor's film reading+AI assisted film reading

Sponsors

The First Affiliated Hospital of Shandong First Medical University (Thousand Buddha Mountain Hospital of Shandong Province)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old, regardless of gender. (2) Simultaneously possessing MRI T1WI, T2WI, and T2FLAIR plain scan sequence images of the brain. (3) To be selected, at least one of the following three conditions must be met: A. Having a tumor like lesion (glioma, meningioma, or brain parenchymal metastasis). B. Having non neoplastic lesions (cerebral infarction, cerebral hemorrhage, or cerebrovascular disease). C. There is no abnormal signal in the intracranial region.

Exclusion criteria

Exclusion criteria: (1) The image does not comply with DICOM standards. (2) MRI images have various artifacts that seriously affect doctors' reading and diagnosis. (3) T1WI, T2WI, and T2FLAIR have sequences with incomplete scanning range or missing layers. (4) MRI imaging of the head after surgery, radiotherapy, and chemotherapy. (5) The brain has other pathological changes except for gliomas, meningiomas, brain parenchymal metastases, cerebral infarction, cerebral hemorrhage, and cerebrovascular diseases. (6) Researchers believe it is not suitable for enrollment

Design outcomes

Primary

MeasureTime frame
Detection rate ;Accuracy;sensitivity;specificity;

Countries

China

Contacts

Public ContactHuaqiang Sheng

The First Affiliated Hospital of Shandong First Medical University (Thousand Buddha Mountain Hospital of Shandong Province)

15898616257@163.com+86 156 1016 4169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026