Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07555002

Prospective User Study and Multicenter Validation of Multimodal Medical Imaging Large Models in the Diagnosis of Common Systemic Diseases

Led by The Third Affiliated Hospital of Southern Medical University · Updated on 2026-05-08

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the diagnostic ability and clinical usefulness of a multimodal medical imaging large model to identify common systemic diseases. This observational study involves multiple centers and compares radiologists' accuracy, sensitivity, and specificity when interpreting images with and without AI assistance. The goal is to confirm the model's reliability and its effect on improving diagnostic efficiency across diverse healthcare settings. The study uses a large retrospective dataset of medical images, including CT and MRI scans, collected from various institutions. Licensed radiologists will review these images in two sessions: one without AI help and another with AI assistance, separated by a washout period. The model was pre-trained on about 1,000,000 cases, and here it will be validated using an independent test group of 1,000 cases. Participants are not directly involved as this is a retrospective study using anonymized data. Researchers will measure diagnostic accuracy using the Area Under the Receiver Operating Characteristic Curve (AUC), along with sensitivity, specificity, and average reading time per case. Clinical report quality and semantic accuracy will also be assessed. The study will last approximately 12 months and does not affect patient treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 12 months

Participants' medical images are evaluated by radiologists without AI assistance and then with AI assistance after a washout period to assess diagnostic accuracy and efficiency.

2 separate reading sessions per participant with a washout period in between

Long-term Monitoring

Duration - Through study completion, approximately 12 months

Data analysis and comparison of diagnostic performance metrics including accuracy, sensitivity, specificity, and reading time are conducted.

No participant visits required

Trial Site Locations

Total: 1 location

1

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510630

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Research Team

T

Tao Li, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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