AI-Assisted Chest-CT Reporting for Enhanced Speed and Quality (The DOUBLE-ACE Study) (DOUBLE-ACE)

June 5, 2026 updated by: Shanghai Zhongshan Hospital

A Multicenter Comparative Study Evaluating the Impact of an AI-Assisted Chest CT Reporting System on Real-world Radiologist Performance: The DOUBLE-ACE Study

The goal of this observational study is to learn if an AI assistant tool can help doctors who read chest CT scans (called radiologists) write their reports faster and just as well or better. Chest CT scans are common pictures taken of the inside of the chest to help with diagnosis. The main questions the study aims to answer are: (1) Does using the AI tool save radiologists time when writing their reports? (2) Are the final reports written with the AI tool's help as good as or better than reports written without it? To answer these questions, researchers will compare two time periods at several hospitals. They will look at how long it took to write reports and how good the reports were, both from a time before the AI tool was available and from a time after it was in regular use. In this study, radiologists will use the AI tool as part of their normal daily work. The tool is built into the computer system they already use to look at scans. Researchers will then measure the time and quality of the reports produced during their regular shifts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

Here we provide a summary of the study's methodological framework, including a description of the AI system under evaluation, key quality control measures, and the data analysis plan. Comprehensive details regarding the full protocol, including eligibility criteria and outcome measures, can be found in the other modules of the study protocol.

  1. Background on the AI System: The study evaluates a clinically deployed AI-assisted reporting system, built upon an advanced multimodal foundation model trained on a large-scale chest CT dataset. Its performance, reliability, and generalizability have been established through rigorous validation on extensive internal and external datasets. Prior reader studies have demonstrated its clinical utility by significantly reducing reporting time through automated draft generation while maintaining or improving report quality, supporting its integration into real-world workflow for this evaluation.
  2. Quality Control: To ensure objective assessment, report quality will be scored by a panel of at least two independent, blinded thoracic radiologists using a standardized rubric, with inter-rater reliability calculated. A study-specific data dictionary and Standard Operating Procedures (SOPs) for data handling and analysis will be implemented to ensure reproducibility and auditability.
  3. Data Analysis Plan: A comparative statistical analysis between pre- and post-implementation groups is planned. Appropriate statistical tests (e.g., Mann-Whitney U test, mixed-effects models) will be applied based on data distribution and variable type. A sample size calculation will be conducted to ensure the study is adequately powered to detect a clinically meaningful difference in the primary efficiency endpoint. The primary analysis will be a paired comparison of outcomes (e.g., report time, quality) between the two phases for the participants who complete both. To address potential attrition (e.g., radiologist turnover during the study year) and the influence of radiologist experience, the analysis plan includes: (1) Accounting for and reporting any participant dropout between phases. (2) Conducting pre-specified subgroup or stratified analyses based on radiologist seniority (e.g., junior vs. senior) to examine its effect on the outcomes.
  4. Confounding Factor Control: To minimize potential bias, the study may identify collective variables (radiologists' sex, years of relevant professional experience, etc.) that may be considered potential confounding factors according to external experts' judgements. Certain patient-related information, such as diagnosis (infection, malignancy, cardiovascular disease, etc.) and clinical scenario (e.g., inpatient, outpatient, emergency), may also be collected retrospectively, where necessary, to evaluate model performance within specific diagnostic subgroups. The study will adopt multiple possible approaches for confounding factor adjustment or analysis, which may include stratified analyses and other related statistical methods.
  5. Potential Adjustments in Study Protocol or Analysis Methods: As the study may involve multiple centers, in case of ethical or administrative restrictions at certain time at specific sites, AI assistance may be temporarily suspended to approximate the scenario without AI assistance at those sites. In such cases, the corresponding results may be reported as the with-AI and without-AI phases, rather than labeling them as baseline and AI-available phases. Furthermore, radiologists who decline to provide demographic or occupational information (e.g., years of professional experience or sex)-variables that may serve as potential confounders-will be excluded from adjusted and stratified analyses that require such covariates. These approaches may need to be incorporated into confounding factor or stratified analyses, and we may update related conditions accordingly when necessary.

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 (Estimated)

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.
75

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.
  • Name: Xiaodan Ye, MD, PhD
  • Phone Number: +86-13761459998
  • Email: yuanyxd@163.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai
        • Principal Investigator:
          • Mengsu Zeng, MD, PhD
        • Contact:
        • Contact:
      • Shanghai, China
        • United Imaging Intelligence, Shanghai, Shanghai
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dinggang Shen, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population is defined as follows:

  1. Radiologists: Attending radiologists who routinely interpret chest CT scans as part of their clinical duties at the participating medical centers.
  2. Chest CT Scans: Clinically indicated, non-contrast chest CT examinations acquired from the patient populations served by the participating centers. The scans are stratified into two groups based on the date of acquisition: before and after the implementation of the AI reporting system.

Description

The study participants include both the radiologists whose performance is evaluated and the chest CT scans they interpret. Eligibility criteria are defined for both.

1. Inclusion Criteria

1.1 For Radiologists

  1. Board-certified radiologists specializing in or routinely performing thoracic imaging.
  2. Employed at one of the participating study centers for the entire duration of both the without-AI and with-AI study periods.
  3. Interpreted a minimum of eligible chest CT scans (e.g., > 50 scans) during both the without-AI and with-AI data collection periods.

1.2 For Chest CT Scans

  1. Non-contrast chest CT examinations performed for any clinical indication.
  2. Scans completed and finalized during the defined with-AI or without-AI study periods.
  3. Patient age 18 years or older at the time of the scan.

2. Exclusion Criteria

2.1 For Radiologists:

  1. Radiologists who joined, left, or were on extended leave (e.g., >4 weeks) from the participating center between the with-AI and without-AI study periods.
  2. Radiologists who interpreted fewer than the minimum required number of eligible scans in either study period.
  3. Radiologists who voluntarily decline to have their de-identified performance data included in the study analysis.
  4. Radiologists who decline to provide demographic or occupational information (e.g., years of professional experience or sex)-variables that may serve as potential confounders-will be excluded from adjusted and stratified analyses that require such covariates.

2.2 For Chest CT Scans

  1. CT scans of pediatric patients (age < 18 years).
  2. Contrast-enhanced chest CT studies.
  3. Studies performed for specific procedural guidance (e.g., biopsy, ablation).
  4. Studies deemed technically inadequate for primary interpretation by radiologist (e.g., severe motion artifact, incomplete study).
  5. Studies for which the AI system fails to generate a valid preliminary report draft. This includes possible system failures, algorithm errors, or cases where the generated draft is deemed technically unusable (e.g., empty, garbled, or based on critically flawed image analysis).
  6. The lack of relevant information (diagnosis, clinical scenario, etc.). Chest CT data will be excluded from corresponding analyses if the required information, which is necessary for confounding control, subgroup analyses, or other pre-specified analyses, is unavailable. Such scenarios include data that cannot be retrospectively retrieved, incompletely recorded, or restricted due to ethical or institutional requirements.

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.
Radiologists with/without chest CT interpretation AI assistant
This study employs a single-arm, within-subjects design. A cohort of radiologists will be followed through two sequential practice phases: (1) Baseline (Control) Phase: Participants interpret and report on chest CT scans using their standard clinical workflow without AI assistance. (2) AI-available phase: The same participants interpret and report on a different set of chest CT scans with the integrated AI-assisted reporting system activated in their workflow.
Device: An AI-assisted reporting system integrated into the clinical workflow, providing automated draft generation to assist with chest CT interpretation
The intervention under evaluation is an AI-assisted diagnostic reporting system, integrated directly into the radiologists' workflow. The system analyzes the CT images in real time using an AI model and automatically generates a structured, preliminary radiology report draft. The interpreting radiologist reviews this AI-generated draft, which is presented within their familiar reporting interface. The radiologist then actively edits, confirms, supplements, or overrides the draft content as necessary before finalizing and signing the report. This intervention is distinguished from other AI tools by its focus on end-to-end reporting efficiency via integrated draft generation within the radiologist's classic workflow. It moves beyond simple abnormality detection or highlighting by generating a complete, structured narrative report draft, aiming to reduce dictation/typing time and minimize oversight of findings.

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
Change in Average Image Interpretation Time
Time Frame: Time of interpretation will be collected once the data become fully available (generally within 2 weeks after the planned primary completion date). Final aggregated analysis will be completed within 3 months after the collection of potential confounders.
Comparison of the average time taken by participating radiologists to complete standard chest CT interpretation tasks, measured both with and without use of the automated interpretation tool. The time will be recorded from the start to the completion of each individual reading case.
Time of interpretation will be collected once the data become fully available (generally within 2 weeks after the planned primary completion date). Final aggregated analysis will be completed within 3 months after the collection of potential confounders.
Change in Chest CT Report Quality Score
Time Frame: Reports will be distributed to external experts for scoring once the data become available, with scoring results returned within 7 days. Final aggregated analysis will be completed within 3 months after the collection of potential confounders.
Comparison of the subjective quality of chest CT reports written with and without automated tool support. Blinded external experts will evaluate the subjective quality of all sampled reports using a 10-point rating scale, with scores ranging from 1 (poorest quality) to 10 (highest quality).
Reports will be distributed to external experts for scoring once the data become available, with scoring results returned within 7 days. Final aggregated analysis will be completed within 3 months after the collection of potential confounders.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiologist Editing Intensity on AI-Generated Report Drafts
Time Frame: Report texts will be collected once the data become fully available (generally within 2 weeks after the planned primary completion date). Final aggregated analysis will be completed within 3 months after the collection of potential confounders.
This measure quantifies the extent of modification a radiologist makes to the initial draft report generated by the AI system. Editing intensity will be algorithmically calculated for each report in the with-AI period. A common method is the normalized edit distance (e.g., Levenshtein distance) or the percentage of text modified between the AI-generated draft and the radiologist's final signed report.
Report texts will be collected once the data become fully available (generally within 2 weeks after the planned primary completion date). Final aggregated analysis will be completed within 3 months after the collection of potential confounders.

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.
Shanghai Zhongshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mengsu Zeng, MD, PhD, Department of Radiology, Zhongshan Hospital, Fudan University
  • Study Director: Dinggang Shen, PhD, United Imaging Intelligence, Shanghai
  • Study Director: Jianying Gu, MD, PhD, Department of Radiology, Zhongshan Hospital, Fudan University
  • Study Director: Dijia Wu, PhD, United Imaging Intelligence, Shanghai

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 (Estimated)

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.
June 1, 2026

Primary Completion (Estimated)

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.
August 1, 2026

Study Completion (Estimated)

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.
December 1, 2026

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).
May 27, 2026

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.
June 5, 2026

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.
June 11, 2026

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.
June 11, 2026

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.
June 5, 2026

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.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • B2025-151(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is an observational study analyzing aggregated, de-identified operational metrics (e.g., radiologist efficiency, report quality scores) derived from routine clinical practice. The data are not collected as part of a prospective clinical trial and are not structured for independent analysis. Findings will be disseminated through peer-reviewed publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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