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The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target dose could meet the design requirements of preoperative plan.
At present, 3D printing templates (3DPT) are divided into non-coplanar templates (3DPNCT) and coplanar templates (3DPCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of 3DPNCT, a considerable number of patients can also complete the treatment with 3DPCT. Moreover, compared with 3DPNCT, 3DPCT has the advantages of accurate needle path control, fast needle path adjustment, convenient for intraoperative real-time optimization, without waiting for printing time, easy for doctors to master, lower cost than 3DPNCT, and easy to carry out at the grass-roots level. Therefore, this study intends to explore 3DPCT technology to further clarify: (1) the accuracy of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors; (2) the short-term efficacy and toxicity of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3DPCT and CT guided RISI | Experimental | All patients were treated with clinical routine treatment: 3DPCT combined with CT guided radioactive seed implantation. Collect patient information and treatment information for analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radioactive seed brachytherapy | Radiation | The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring. 3D-printing coplanar template includes information on the path of the implantation needle, the needle path can be controlled accurately which can make the operation more accurate. |
| Measure | Description | Time Frame |
|---|---|---|
| Local progression free survival | The time from the date of SBRT to the date of local recurrence or death or the date of last observation. | From the beginning of the treatment to 2 years after the treatment. |
| Incidence of adverse events | The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured. | From the beginning of the treatment to 2 years after the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from the date of seeds implantation to the date of death from any cause or the date of last observation. | From the beginning of the treatment to 2 years after the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Ji, M.D. | Contact | 008618710002823 | aschoff@163.com | |
| Junjie Wang, M.D. | Contact | 008601082265921 | junjiewang_edu@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 month after the study completion.
Data access requests will be reviewed by the research sponsor. Requestors will be required to sign a Data Access Agreement.
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