- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810274
3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal Carcinoma
January 16, 2019 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing
3DV+TPS Software Outlines the Outline of Radiotherapy for Nasopharyngeal Carcinoma Center Comparison Study Clinical Research
Comparing the accuracy and speed of 3DV+TPS software with imported TPS and domestic TPS to outline the contours of crisis organs, it is proved that 3DV+TPS has superiority compared with domestic TPS, and it has non-inferiority compared with imported TPS, indicating that the software can improve contour sketching accuracy.
And speed, reduce the burden on doctors, improve medical efficiency.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Comparing the accuracy and speed difference between 3DV+TPS software and imported TPS and domestic TPS to outline the contours of crisis organs, the selected organs are: bilateral eyeballs, bilateral crystals, bilateral optic nerves, bilateral parotid glands, oral cavity, spinal cord, brainstem, The brain has a total of 12 organs; verify that 3DV+TPS is superior to domestic TPS, and has non-inferiority compared with imported TPS, Ming software can improve the accuracy and speed of contour sketching, reduce the burden on doctors, and improve medical efficiency.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chongqing, China, 400000
- Xinqiao Hospital of Chongqing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A total of 7 different grade hospital radiotherapy centers have received radiotherapy for patients with nasopharyngeal carcinoma Case information, based on inclusion and exclusion criteria, a total of 300 cases were screened.
Among them, Xinqiao Hospital collected 180 cases, He collected 20 cases in 20 hospitals, totaling 200 cases.
Description
Inclusion Criteria:
- It is diagnosed as nasopharyngeal carcinoma by histopathological examination, and there is no tumor invasion in the organs that need to be assessed;
- Age 18-70 years old;
- There is nasopharynx localization enhanced CT, nasopharynx enhanced MRI.
Exclusion Criteria:
- Patient information is incomplete; no age, gender, MRI, height, radiotherapy location CT;
- The organs at risk that need to be assessed are invaded by the tumor;
- Any reason cannot be combined with the research or the researcher believes that it is not suitable for inclusion in this test.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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3DV+TPS
This experiment included a total of 300 patients with nasopharyngeal carcinoma, using 3DV + TPS software and imported TPS, domestic TPS, these three sets of TPS delineate bilateral crystal, bilateral optic nerve, bilateral eyeball, bilateral parotid gland, oral cavity, spinal cord There are 12 organs in the brainstem and brain, and the accuracy and speed of the 3 sets of TPS sketches are compared.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sketching accuracy
Time Frame: one year
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Define ΔV as a percentage of the total volume of the gold standard;
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one year
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Sketch speed
Time Frame: one year
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Use the stopwatch to record the total time used to draw down 12 organs, to start sketching as the starting point of the time, and to finish the saving of the data.
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2012
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
January 15, 2019
Study Registration Dates
First Submitted
January 11, 2019
First Submitted That Met QC Criteria
January 16, 2019
First Posted (Actual)
January 18, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2019
Last Update Submitted That Met QC Criteria
January 16, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- XQonc-012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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