Prospective User Study and Multicenter Validation of Multimodal Medical Imaging Large Models

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Third Affiliated Hospital of Southern Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients who underwent systemic medical imaging examinations (e.g., CT or MRI) at participating centers for common systemic diseases.

Imaging data must have confirmed clinical reference standards, expert consensus, or pathological diagnosis.

Availability of complete DICOM format images with standard acquisition protocols.

Disqualifiers

Poor image quality (e.g., severe motion or metal artifacts) that precludes definitive diagnosis.

Cases with incomplete clinical or pathological reference standards.

Corrupted image files or duplicate cases.

Trial population

Patients from multiple medical centers in China who underwent systemic medical imaging for various clinical indications, representing a broad range of common systemic diseases.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Standalone Radiologist Interpretation

    Other intervention

    Radiologists interpret the medical images independently without any assistance from the AI model to establish a baseline performance.

  • AI-assisted Radiologist Interpretation

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Validation Cohort2 interventions

Trial outcomes

Primary outcomes

1

Area Under the Receiver Operating Characteristic Curve (AUC)

Evaluation of diagnostic accuracy using AUC to compare standalone radiologist performance versus AI-assisted performance.

Time frame
Through study completion, approximately 12 months.

Secondary outcomes

1

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.

Time frame
Through study completion, approximately 12 months.
2

Clinical Report Quality and Semantic Accuracy Score

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.

Time frame
Through study completion, approximately 12 months.
3

Sensitivity and Specificity

To calculate and compare the sensitivity and specificity of radiologists' diagnostic decisions in both standalone and AI-assisted sessions.

Time frame
Through study completion, approximately 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.