Precise Image for Interventional CT

August 21, 2026 updated by: Philips Clinical & Medical Affairs Global

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale
Time Frame: 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)
Reading session at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2027

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SEF-2025-301308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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