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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03810274
Other study ID # XQonc-012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2012
Est. completion date January 15, 2019

Study information

Verified date January 2019
Source Xinqiao Hospital of Chongqing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 15, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. It is diagnosed as nasopharyngeal carcinoma by histopathological examination, and there is no tumor invasion in the organs that need to be assessed;

2. Age 18-70 years old;

3. There is nasopharynx localization enhanced CT, nasopharynx enhanced MRI.

Exclusion Criteria:

1. Patient information is incomplete; no age, gender, MRI, height, radiotherapy location CT;

2. The organs at risk that need to be assessed are invaded by the tumor;

3. Any reason cannot be combined with the research or the researcher believes that it is not suitable for inclusion in this test.

Study Design


Intervention

Device:
3DV+TPS;VARIAN TPS;FonicsPlan


Locations

Country Name City State
China Xinqiao Hospital of Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sketching accuracy Define ?V as a percentage of the total volume of the gold standard; one year
Primary Sketch speed 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. one year
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