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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Type of examination: standard digital orthopantomogram of the chest during the study period.
  2. Completeness of information: Medical records containing basic information, medical history, etc.
  3. Informed consent: written consent form signed by the patient or legal representative.

Exclusion Criteria:

  1. Anatomical abnormalities: congenital abnormalities of chest development, history of chest surgery, or severe scoliosis that interfere with image interpretation.
  2. Poor image quality: chest radiographs with severe artifacts, exposure abnormalities, or incomplete images.
  3. Acutely ill: life-threatening and unable to cooperate with the study process.
  4. Mental cognitive problems: suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
  5. Pregnant: Fetus is radiosensitive and physiological changes during pregnancy affect the images.
  6. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Janus-Pro-CXR
Other: AI-generated report for reference
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Union Hospital, China

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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