NCT06456203

Brief Summary

Randomized Clinical Trial of the impact of Chest radiograph AI-assisted triage and report generation upon clinical outcomes and an economic analysis of impact of AI decision support on radiology service delivery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

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

June 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

June 4, 2024

Last Update Submit

June 11, 2024

Conditions

PneumoniaLung Cancer

Keywords

Radiologyartificial intelligencetriageradiography

Outcome Measures

Primary Outcomes (3)

  • Report generation time

    Time for radiologist to produce each individual CXR report

    12 months

  • Turnaround Time

    Time from patient arrival at radiography department to time for clinical team to receive report

    12 months

  • Time to discharge

    Time from patient arrival at radiography department to time to discharge from hospital

    12 months

Secondary Outcomes (1)

  • 30-day patient readmission rate

    12 months

Study Arms (2)

Control Arm

NO INTERVENTION

Chest radiographs reported with AI assistance

AI assisted

ACTIVE COMPARATOR

AI assisted detection, triage and reporting of CXR

Diagnostic Test: AI

Interventions

AIDIAGNOSTIC_TEST

Artificial intelligence triage and reporting system

AI assisted

Eligibility Criteria

Age14 Years - 130 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients attending radiography to have chest radiographs during the study period

You may not qualify if:

  • age below 14
  • deceased before discharge
  • chest radiograph performed in non-standard projections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PneumoniaLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 13, 2024

Study Start

October 1, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share