Clinical Study for P-MAR

NCT07317479 | Not Yet Recruiting

• 1 other identifier: Precise MAR
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.To demonstrate non-inferiority of P-MAR compared to images without metal correction for the relevant metal groups.

Conditions

Computed Tomography

Outcome Measures

Primary Outcomes (1)

• The extent of metal artifacts and diagnostic confidence of P-MAR

  The extent of metal artifacts and diagnostic confidence of P-MAR reconstructions is at least as good as (non-inferior to) images without metal correction, for CT images (with metal present) of adult patients (\>18 years old).

  Reading session at 4 months

Eligibility Criteria

• Age: 18 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.
• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

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: January 31, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-09