NCT06589934

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

September 6, 2024

Last Update Submit

November 24, 2025

Conditions

Precise Image (AI Reconstruction Feature of CT 5400 RT System)

Outcome Measures

Primary Outcomes (1)

  • Clinical image quality(IQ)

    Image quality will be assessed by Likert score (1-5)

    14 days (anticipated)

Study Arms (1)

Image quality

EXPERIMENTAL

Diagnostic Test -Good and excellent rate of PI image quality is greater than or equal to 95%. PI image quality will be assessed by using the retrospective image raw data obtained from CT 5400 RT (applicable body parts include: head, neck, chest, abdomen and coronary)

Diagnostic Test: Precise Image

Interventions

Precise ImageDIAGNOSTIC_TEST

Image reconstruction software

Image quality

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • image raw data generated from CT 5400 RT system validation clinical trial (protocol name: Clinical study of CT 5400 RT for system validation, ClinicalTrials.gov ID: NCT06466577)
  • Applicable body parts include: head, neck, chest, abdomen and coronary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200120, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

January 25, 2025

Primary Completion

January 25, 2025

Study Completion

March 25, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

CN(1)