Precise Image for Interventional CT

NCT07317427 | Not Yet Recruiting

• 1 other identifier: SEF-2025-301308
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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. 1.To evaluate the image quality for procedural guidance of Precise Image compared to the standard-of-care reference (iDose4) for:
2. 2.To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.

Conditions

Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale

  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)

  Reading session at 4 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Healthcare (Suzhou) Co., Ltd.: collaborator
• Philips Clinical & Medical Affairs Global: lead

Study Design

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

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 5, 2026
• Study Start (Estimated): January 31, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08