Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts

A Comparative Study of Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts

1. Compare the effect of virtual single energy imaging and virtual single energy combined with MAR technology to remove metal artifacts in the spine. 2. Discuss the most suitable KeV of virtual single energy imaging combined with MAR technology to remove metal artifacts.

Study Overview

• Status: Completed
• Conditions: Spinal Disease
• Intervention / Treatment: Diagnostic test: Virtual single energy combined with MAR reconstruction group

Detailed Description

The virtual single-energy imaging of energy spectrum CT combined with the metal artifact reduction technology MARS Multi Artifact Reduction System] can effectively reduce the interference of metal artifacts. This is because MAR technology corrects the image through an iterative algorithm, improves the spatial resolution, and restores the details of the adjacent tissue of the metal object. Virtual single-energy imaging technology can effectively reduce hardening artifacts. The two are used in combination to achieve the purpose of reducing metal artifacts. There have been articles about virtual single energy combined with MAR technology to reduce metal artifacts. However, the current researches mostly focus on the comparison of virtual single energy combined with MAR technology and conventional CT examination and virtual single energy imaging. There are few evaluations on the severity of metal artifacts after spinal surgery. According to different surgical methods, metal The difference in the number of implants will result in different artifact reduction effects. Secondly, the current research on the suitable KeV of virtual single energy combined with MAR technology to reduce metal artifacts is less discussed and reported.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects were selected from patients who planned to undergo routine spinal postoperative CT examinations in the radiology department from December 2018 to February 2019 in Peking University Third Hospital.

Description

Inclusion Criteria:

• Patients undergoing surgery due to lumbar disc herniation or prolapse
• Patients undergoing surgical correction due to vertebral deformities.

Exclusion Criteria:

• The scan image quality caused by the patient's movement and other factors is too poor to meet the diagnostic requirements.
• Patients with only spinous processes and intervertebral spaces undergoing metal fixation after spine surgery
• Patients after spinal cord tumor surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Virtual single-energy imaging reconstruction group; Rebuild a virtual single energy map (70-140Kev, interval 10Kev)
Virtual single energy (70-140Kev, interval 10Kev) combined with MAR reconstruction group; Rebuild a virtual single energy map (70-140Kev, interval 10Kev) combined with MAR reconstruction group	Diagnostic test: Virtual single energy combined with MAR reconstruction group; combined with MAR reconstruction group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Artifact Index	Select the largest level of artifacts in the image, place a region of interest (ROI) with an area of 100-150mm2 in the soft tissue around the metal and spinal canal for CT value and standard deviation (SD) measurement, avoid the boundary area, and measure the ROI area Artifact Index ASelect the largest level of artifacts in the image, place a region of interest (ROI) with an area of 100-150mm2 in the soft tissue around the metal and spinal canal for CT value and standard deviation (SD) measurement, avoid the boundary area, and measure the ROI area Artifact Index AI	2019.2.1-2019.2.15

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): December 3, 2018
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (ACTUAL): July 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: M2018180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No