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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04955483
Other study ID # M2018180
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date February 1, 2019

Study information

Verified date December 2018
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date February 1, 2019
Est. primary completion date December 3, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Virtual single energy combined with MAR reconstruction group
combined with MAR reconstruction group

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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