NCT03810274

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

6.9 years

First QC Date

January 11, 2019

Last Update Submit

January 16, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sketching accuracy

    Define ΔV as a percentage of the total volume of the gold standard;

    one year

  • 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

Study Arms (1)

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.

Device: 3DV+TPS;VARIAN TPS;FonicsPlan

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinqiao Hospital of Chongqing

Chongqing, 400000, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 18, 2019

Study Start

February 1, 2012

Primary Completion

December 31, 2018

Study Completion

January 15, 2019

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations