RadiotherapyNCT03810274
3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal Carcinoma
An observational study of Radiotherapy and Nasopharyngeal Carcinoma, run by Xinqiao Hospital of Chongqing at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiotherapy, Nasopharyngeal Carcinoma
- What is being tested?
- 3DV+TPS；VARIAN TPS；FonicsPlan
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 15 Jan 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiotherapy, Nasopharyngeal Carcinoma
- Being tested
- 3DV+TPS；VARIAN TPS；FonicsPlan
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DV+TPS；VARIAN TPS；FonicsPlanDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 3DV+TPS；VARIAN TPS；FonicsPlan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sketching accuracy
Define ΔV as a percentage of the total volume of the gold standard;
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Feb 2012
- Primary completion31 Dec 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810274
- Sponsor's protocol ID
- XQonc-012
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3DV+TPS Software Outlines the Outline of Radiotherapy for Nasopharyngeal Carcinoma Center Comparison Study Clinical Research
- ClinicalTrials.gov ID
- NCT03810274
- Acronym / sponsor ID
- XQonc-012
- Conditions
- Radiotherapy, Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 18 Jan 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DV+TPS | – | Device: 3DV+TPS；VARIAN TPS；FonicsPlanThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| 3DV+TPS；VARIAN TPS；FonicsPlan | Device | 3DV+TPS |
Primary outcome
Sketching accuracy
Time frame: one year
Define ΔV as a percentage of the total volume of the gold standard;
Sketch speed
Time frame: one year
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.
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 18 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiotherapy and Nasopharyngeal Carcinoma, run by Xinqiao Hospital of Chongqing 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 3 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 18 Jan 2019. 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?
Sketching accuracy (time frame: one year). The study lists 2 primary outcomes in all. 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 18 Jan 2019.