Clinical Study for P-MAR (Precise MAR)

Philips

Status: Not yet enrolling

Conditions: Computed Tomography

Study type: Observational

Funder types: Industry

Identifiers

NCT07317479

Precise MAR

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
• 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.