Clinical Study for P-MAR

N/ANot Yet RecruitingNCT07317479

Philips Clinical & Medical Affairs Global120 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Computed Tomography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Reading session at 4 months

Data from ClinicalTrials.gov

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