Precise Image for Interventional CT

Clinical Study for Precise Image for Interventional CT for Incisive CT and CT 5300 Systems

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07317427

Enrollment

Registered

2026-01-05

Start date

2027-01-31

Completion date

2027-12-01

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computed Tomography

Brief summary

The purpose of this clinical study is to assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (\>18 years old). The analysis will focus on the performance of Precise Image for scans in which procedural instruments (e.g., needle, probe, screw) are present. Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image. The study has two objectives: 1. To evaluate the image quality for procedural guidance of Precise Image compared to the standard-of-care reference (iDose4) for: o Interventional CT images of adult patients (\>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable clinical scans. * Subject age: \>18 years old. * Presence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.

Exclusion criteria

* Subject age: 18 years old and below. * Absence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images. * Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp). * Scans that the site interventional radiologists have deemed non-suitable for procedural guidance. * Scans that the site interventional radiologists have deemed non-suitable for procedural guidance.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale	Reading session at 4 months	The image quality of Precise Image reconstructions will be considered at least as good as (non-inferior to) that of iDose4 reconstructions for interventional CT images (CCT single, continuous, fluoro) of adult patients (\>18 years old)

Outcome results