NCT07040358

Brief Summary

This study aims to develop an AI-assisted diagnostic system for abdominal contrast-enhanced CT images using data from multiple inpatient centers. In collaboration with Alibaba DAMO Academy, the project will address key mathematical challenges limiting current automated image interpretation, including feature space alignment, hybrid reasoning, and multimodal report generation. The study includes the following components: (1) construction of a dual-modality foundation model to align abdominal CT features with corresponding radiology reports; (2) development of a model to standardize CT phase variation among patients; and (3) creation of an automated image interpretation and reporting system that integrates multi-source clinical data. The effectiveness of the system will be evaluated through a report quality assessment framework and clinical validation. This project aims to improve the accuracy and clinical applicability of automated abdominal disease interpretation and promote intelligent innovation in healthcare delivery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000,000

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Dec 2023Jun 2026

Study Start

First participant enrolled

December 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

June 19, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

Artificial Intelligenceabdominal diseasescontrast-enhanced CTRADAR

Outcome Measures

Primary Outcomes (1)

  • Performance of AI Model for Lesion Detection on Abdominal Contrast-Enhanced CT

    The primary outcome is the overall performance of the AI model in detecting and characterizing lesions in abdominal organs using multiphase contrast-enhanced CT scans. Performance will be measured using area under the receiver operating characteristic curve (AUC), F1-score, sensitivity, and specificity, with expert radiologist consensus reports as the reference standard.

    After internal and external validation datasets are processed (estimated 6-12 months)

Study Arms (3)

Internal Training Set

Internal Validation Set

External Test Set

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study uses a retrospective multicenter cohort comprising approximately 2 million cases of multiphase contrast-enhanced abdominal CT scans. All included imaging data are paired with corresponding radiology reports. The dataset reflects real-world imaging scenarios of various abdominal diseases.

You may qualify if:

  • multiphase contrast-enhanced abdominal CT covering the full abdominal region and corresponding radiology reports matched to the CT images

You may not qualify if:

  • CT images with poor diagnostic quality due to artifacts, including but not limited to: Convolution artifacts caused by improper arm positioning (e.g., arms placed alongside the body instead of above the head),Respiratory motion artifacts due to inadequate breath-holding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2025

First Posted

June 27, 2025

Study Start

December 1, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations