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Clinical trial for validating the safety and effectiveness of MRI-based brain tumor computer-aided diagnosis software

Clinical trial for validating the safety and effectiveness of MRI-based brain tumor computer-aided diagnosis software - Clinical trial of MRI-based computer-aided diagnosis software for brain tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113580
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-12
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Brain tumor

Interventions

Gold Standard:Joint image review by the expert panel and pathological findings
Index test:Brain Tumor MRI Auxiliary Diagnosis Software

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. MRI acquisition performed using equipment with a field strength of 1.5 T or higher; 3. Complete multimodal brain MRI data available, including DICOM-standard images acquired in compliance with T1ce and T2 FLAIR sequence specifications.

Exclusion criteria

Exclusion criteria: 1. Images that do not meet the DICOM standard; 2. Images that are discontinuous, incomplete, or exhibit misalignment or slice loss; 3. Cases with severe artifacts or noise that interfere with evaluation; 4. Diffuse lesions without a defined intracranial mass; 5. Cases with concomitant diseases such as stroke that may interfere with tumor imaging; 6. Cases deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Sensitivity for brain tumor lesion detection;Specificity for brain tumor lesion detection;AFROC-AUC for brain tumor lesion detection;ROC-AUC for brain tumor lesion diagnosis;

Countries

China

Contacts

Public ContactDaoying Geng

Huashan Hospital, Fudan University

gengdy@163.com+86 21 5288 8365

Outcome results

None listed

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