NCT06874647

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 23, 2025

Status Verified

March 1, 2025

Enrollment Period

21 days

First QC Date

March 9, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

radiologyartificial intelligenceLarge language model

Outcome Measures

Primary Outcomes (3)

  • Report Quality Score and agreement score

    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

    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

    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

Study Arms (2)

Janus-Pro-CXR

Other: AI-generated report for reference

SCP

Interventions

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.

Janus-Pro-CXR

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients requiring chest X-ray

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The First Affiliated Hospital of Henan University of science and technology

Luoyang, Henan, 471003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450002, China

Location

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430023, China

Location

Related Publications (1)

  • Tanno R, Barrett DGT, Sellergren A, Ghaisas S, Dathathri S, See A, Welbl J, Lau C, Tu T, Azizi S, Singhal K, Schaekermann M, May R, Lee R, Man S, Mahdavi S, Ahmed Z, Matias Y, Barral J, Eslami SMA, Belgrave D, Liu Y, Kalidindi SR, Shetty S, Natarajan V, Kohli P, Huang PS, Karthikesalingam A, Ktena I. Collaboration between clinicians and vision-language models in radiology report generation. Nat Med. 2025 Feb;31(2):599-608. doi: 10.1038/s41591-024-03302-1. Epub 2024 Nov 7.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 13, 2025

Study Start

March 10, 2025

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 23, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations