NCT07121283

Brief Summary

AI-Assisted Bone Age Assessment

Trial Health

75
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress71%
Sep 2025Aug 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2026

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

July 30, 2025

Last Update Submit

April 14, 2026

Conditions

Bone Age

Outcome Measures

Primary Outcomes (1)

  • Difference of Skeletal Age Estimate

    Mean absolute difference of bone age assessment between true AI-assisted and fake AI-assisted among radiologists

    Five months

Study Arms (2)

True AI

EXPERIMENTAL
Device: True AI

Fake AI

EXPERIMENTAL
Device: Fake AI

Interventions

True AIDEVICE

True output from bone age AI

True AI
Fake AIDEVICE

Randomized output from bone age AI

Fake AI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Exams read by radiologists who interpret pediatric skeletal age exams and verbally consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taiwan, 112, Taiwan

Location

Study Officials

  • Yen-Huai Lin, Dr.

    Cheng-Hsin General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Six radiologists with different seniority (senior, intermediate, and junior) were recruited. The 200 standard films were evenly divided into two subsets: datasets A and B. A randomized crossover design with four periods (each with a 4-week duration) was arranged to minimize anticipation and carryover effects. Each radiologist who made an assessment with the aid of true AI or fake AI information could agree or disagree with the AI's predictions. The information of the fake AI was resulted from the randomization of the outputs from the true AI. Each radiologist was blinded to the existence of the fake AI.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 13, 2025

Study Start

September 1, 2025

Primary Completion

February 18, 2026

Study Completion (Estimated)

August 18, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)