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This study aims to evaluate the diagnostic performance and clinical utility of a multimodal medical imaging large model in identifying common systemic diseases. Through a retrospective reader study involving multiple centers, the research will compare the diagnostic accuracy, sensitivity, and specificity of radiologists with and without AI assistance. The goal is to validate the model's robustness and its impact on the diagnostic efficiency of clinicians across diverse healthcare settings.
Background: Multimodal large models have shown significant potential in medical imaging. However, their performance and impact on clinical workflows across multiple centers require rigorous validation.
Objective: To assess the diagnostic performance of a multimodal large model and investigate whether AI assistance can improve the diagnostic accuracy and efficiency of radiologists with varying levels of experience.
Methodology: This research is designed as a multicenter, retrospective comparative reader study. A large-scale, diverse dataset of medical images (including CT and MRI) will be curated from the participating institutions. A group of licensed radiologists will perform diagnostic tasks in two separate sessions: a standalone session (without AI assistance) and an AI-assisted session, with a suitable washout period between sessions.
Data Analysis: The clinical "ground truth" will be established by expert consensus or histological results. The study will compare the Area Under the Receiver Operating Characteristic Curve (AUC), sensitivity, and specificity between the standalone and AI-assisted modes. Additionally, the reading time per case will be recorded to evaluate diagnostic efficiency.
Ethics: This study uses retrospective, anonymized data and does not alter the clinical management or treatment of patients.
The multimodal large model was developed and pre-trained using a massive dataset of approximately 1,000,000 medical imaging cases. This study focus on the multicenter clinical validation using an independent test cohort of 1,000 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validation Cohort | A retrospective dataset of medical imaging cases (including CT and MRI) collected from multiple centers, representing common systemic diseases, used to evaluate the diagnostic performance of the multimodal large model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standalone Radiologist Interpretation | Other | Radiologists interpret the medical images independently without any assistance from the AI model to establish a baseline performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (AUC) | Evaluation of diagnostic accuracy using AUC to compare standalone radiologist performance versus AI-assisted performance. | Through study completion, approximately 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Reading and Reporting Time per Case | Assessment of diagnostic efficiency by recording the time (in seconds) taken by radiologists to complete the diagnosis and generate reports, with and without AI assistance. | Through study completion, approximately 12 months. |
| Clinical Report Quality and Semantic Accuracy Score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from multiple medical centers in China who underwent systemic medical imaging for various clinical indications, representing a broad range of common systemic diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Li, MD | Contact | +86-15527360835 | lt12420131@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yinghua Zhao, PhD | The Third Affiliated Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510630 | China |
To protect patient privacy and comply with institutional data security regulations.
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| AI-assisted Radiologist Interpretation | Other | Radiologists interpret the same set of medical images with the assistance of the multimodal medical imaging large model to evaluate the improvement in diagnostic performance. |
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The quality of AI-generated reports will be evaluated by senior experts using a 5-point Likert scale, focusing on semantic accuracy, clinical relevance, and completeness of the descriptions. The scale ranges from 1 to 5, where 1 indicates "poor quality" and 5 indicates "excellent quality." Higher scores represent better report quality and higher semantic accuracy. |
| Through study completion, approximately 12 months. |
| Sensitivity and Specificity | To calculate and compare the sensitivity and specificity of radiologists' diagnostic decisions in both standalone and AI-assisted sessions. | Through study completion, approximately 12 months. |