Spinal DiseaseNCT04955483
Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts
An observational study of Spinal Disease, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Virtual single energy combined with MAR reconstruction group
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients undergoing surgery due to lumbar disc herniation or prolapse
- Patients undergoing surgical correction due to vertebral deformities.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts
- 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.
Read the 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.
- Conditions
- Spinal Disease
- Being tested
- Virtual single energy combined with MAR reconstruction group
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual single energy combined with MAR reconstruction groupDiagnostic test
combined with MAR reconstruction group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Virtual single energy combined with MAR reconstruction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2019.2.1-2019.2.15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Dec 2018
- Primary completion3 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Dr., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955483
- Sponsor's protocol ID
- M2018180
- Status last verified
- Dec 2018
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts
- ClinicalTrials.gov ID
- NCT04955483
- Acronym / sponsor ID
- M2018180
- Conditions
- Spinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Virtual single energy combined with MAR reconstruction groupRebuild a virtual single energy map (70-140Kev, interval 10Kev) combined with MAR reconstruction group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing surgery due to lumbar disc herniation or prolapse
- Patients undergoing surgical correction due to vertebral deformities.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual single energy combined with MAR reconstruction groupcombined with MAR reconstruction group | Diagnostic test | Virtual single energy (70-140Kev, interval 10Kev) combined with MAR reconstruction group |
Primary outcome
Artifact Index
Time frame: 2019.2.1-2019.2.15
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huishu Yuan, Dr. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Artifact Index (time frame: 2019.2.1-2019.2.15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.