Precise Image for Interventional CT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Computed Tomography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study for Precise Image for Interventional CT for Incisive CT and CT 5300 Systems
Overview
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 and procedural confidence of Precise Image compared to the standard-of-care reference (iDose4) for: * 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.
Primary outcome measures
- Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale [Time frame: Reading session at 4 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07317427 · Precise Image for CCT