- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874647
Chest X-Ray Image Diagnosis and Report Generation Dedicated Model Based on Deepseek
April 17, 2025 updated by: Wuhan Union Hospital, China
Large Language Models for Chest X-Ray Image Diagnosis and Report Generation: A Stepwise, Multicenter, Early-Stage Clinical Validation Study
The global shortage of radiologists is a pressing issue, particularly in regions with limited medical resources.
Against this backdrop, making report generation the core objective of radiology AI systems not only aligns with the practical needs of radiologists but also better serves patient requirements.
With the development of multimodal large models, it has become possible to develop automatic report generation systems for medical images.
Although ChatGPT 4o has demonstrated certain capabilities in multiple medical sub - fields, as a closed - source system, it has limitations.
Its model generation mechanism is opaque, and issues such as hallucination exist.
Recently, Deepseek's open - source multimodal large model, Janus - Pro, an "any to any" model, has the advantages of high performance, low cost, and open - source.
Nature published three consecutive articles introducing its stunning features.
After training and fine - tuning, Janus - Pro shows great potential in medical image diagnosis and report generation.
However, currently, the application of Janus - Pro in image diagnosis has not been evaluated.
Most existing models are highly versatile but lack optimization for specific domains, and there is a lack of systematic and multi - dimensional evaluation methods to determine the pros and cons of multimodal large models in medical radiology.
Based on these current situations, the purpose of our research is to develop and verify the application value of large models dedicated to medical images in image diagnosis and radiology report generation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471003
- The first affiliated hospital of Henan University of science and technology
-
Zhengzhou, Henan, China, 450002
- The first affiliated hospital of Zhengzhou university
-
-
Hubei
-
Wuhan, Hubei, China, 430023
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients requiring chest X-ray
Description
Inclusion Criteria:
- Type of examination: standard digital orthopantomogram of the chest during the study period.
- Completeness of information: Medical records containing basic information, medical history, etc.
- Informed consent: written consent form signed by the patient or legal representative.
Exclusion Criteria:
- Anatomical abnormalities: congenital abnormalities of chest development, history of chest surgery, or severe scoliosis that interfere with image interpretation.
- Poor image quality: chest radiographs with severe artifacts, exposure abnormalities, or incomplete images.
- Acutely ill: life-threatening and unable to cooperate with the study process.
- Mental cognitive problems: suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
- Pregnant: Fetus is radiosensitive and physiological changes during pregnancy affect the images.
- Participation in other studies: concurrent participation in other programs that affect the results of this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Janus-Pro-CXR
|
The Janus-Pro-CXR group has the AI-generated report for reference and can make changes to the AI-generated report.
Another group completes the report independently.
|
|
SCP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Report Quality Score and agreement score
Time Frame: No more than 1 week
|
The evaluation assessed the reports generated by the SCP group and the AI-assisted group, using a five-point Likert scale (5 being the best, 1 being the worst) to subjectively evaluate the capability of the large model in generating imaging reports.
The RADPEER scoring system was used to assess the agreement between the original reports and the generated reports, including the clinical significance of any discrepancies.
|
No more than 1 week
|
|
Pairwise preference
Time Frame: No more than 1 week
|
For each evaluator, they must select the better report between the one generated by the large model and the published report.
The proportion of cases where three or more evaluators agreed that the AI-assisted group's reports were superior to those of the SCP group was calculated.
|
No more than 1 week
|
|
Reading Time
Time Frame: No more than 1 week
|
To evaluate the impact of the large model on workflow efficiency, the reading time-defined as the duration from when a radiologist begins reviewing a chest X-ray to the completion of the final radiology report-was measured and automatically recorded by the system.
|
No more than 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2025
Primary Completion (Actual)
March 31, 2025
Study Completion (Actual)
March 31, 2025
Study Registration Dates
First Submitted
March 9, 2025
First Submitted That Met QC Criteria
March 9, 2025
First Posted (Actual)
March 13, 2025
Study Record Updates
Last Update Posted (Actual)
April 23, 2025
Last Update Submitted That Met QC Criteria
April 17, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Janus-Pro-CXR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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