NCT05351268

3DPCT Combined With CT Guided RISI in the Treatment of Thoracic Malignant Tumors

Safety and Efficacy of 3D Printing Coplanar Template Combined With CT Guided Radioactive I-125 Seed Implantation in the Treatment of Thoracic Malignant Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Radioactive Iodine-125 Brachytherapy
• Thoracic Cancer
• 3D Printing Coplanar Template
• Nuclear Radiation Effects

Interventions

Type	Name	Description
RADIATION	Radioactive seed brachytherapy	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-04-30
• Completion: 2026-04-30
• First posted: 2022-04-28
• Last updated: 2023-12-20

Locations

1 site across 1 country: China