Spinal Disease Clinical Trial
Official title:
A Comparative Study of Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts
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 |
Verified date | December 2018 |
Source | Peking University Third Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
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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