NCT07767201

Brief Summary

The objective of the study is to evaluate the Image Quality (IQ), and diagnostic acceptability of Precise Image (PI) as compared with iDose4 as a standard-of-care reference. The study is designed to assess the performance of Precise Image algorithm on data collected from subjects scanned by CT Rembra RT, CT Areta RT or CT Rembra. This approach allows for the evaluation of image quality and diagnostic acceptability by comparing the PI algorithm with iDose4, which serves as the standard-of-care reference.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

August 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 11, 2026

Last Update Submit

August 11, 2026

Conditions

CT ScansPrecise Image (AI Reconstruction Feature of CT 7500 RT System)

Outcome Measures

Primary Outcomes (1)

  • Acceptability of Precise Image reconstruction

    The Image Quality and diagnostic acceptability of Precise Image reconstructions are at least as good as (non-inferior to) iDose4 for conventional images.

    5 months from enrollment

Eligibility Criteria

Age23 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects that are adults over the age of 22 years and scanned by CT Rembra RT, CT Areta RT or CT Rembra.

You may qualify if:

  • Subjects scanned by CT Rembra RT, CT Areta RT or CT Rembra according to the department standard of care clinical protocols.
  • Subjects age \> twenty-two (22) years

You may not qualify if:

  • Scans that the site radiologists/medical physicists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement)
  • Scans that are not completed due to technical difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 17, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

August 17, 2026

Record last verified: 2026-08