Clinical Study for P-MAR
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 P-MAR Metal Artifact Reduction Algorithm for Incisive CT and CT 5300 Systems
Overview
The purpose of this clinical study is to evaluate the performance of the P-MAR metal artifact reduction algorithm for CT imaging (with metal present) of adult patients (\>18 years old). The study has two objectives: 1. To evaluate the extent of metal artifacts and diagnostic confidence, and overall image quality (independent of metal artifacts) of P-MAR compared to images without metal correction, and compared to O-MAR, for CT images (with metal present) of adult patients (\>18 years old). 2. To demonstrate non-inferiority of P-MAR compared to images without metal correction for the relevant metal groups.
Primary outcome measures
- The extent of metal artifacts and diagnostic confidence of P-MAR [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.
- Subject age: Above 18 years old.
- Scans with metal present (orthopedic implants/joint prothesis, dental filling/implants, spine screw(s), pacemaker, coils, radiotherapy beads, surgical clips/staples, metal objects either outside the body or near air, etc.)
Exclusion criteria
- Subject age: 18 years old and below.
- CT scans with no metal present.
- CT scans with metal with motion artifacts.
- Surview or Locator/Tracker.
- CT scans performed utilizing respiratory gating (e.g., "pulmo gating").
- CT scans performed utilizing cardiac gating.
- CT Perfusion scans.
- CCT scans.
- Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
- Scans that are not completed due to technical difficulties.
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: NCT07317479 · Precise MAR