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
Peking University Third Hospital
30 participants
May 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Pathological diagnosis of malignant tumor of chest, lesion diameter less than 7 cm.
- There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by early treatment.
- No bleeding tendency, anticoagulant therapy and / or antiplatelet coagulation drugs should be stopped for at least 1 week before treatment.
- No serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction) are found.
- There is a suitable puncture path, and the therapeutic dose is expected to be achieved.
- KPS \> 70, expected to tolerate puncture / seed implantation, and expected survival time greater than 3 months.
Exclusion Criteria6
- Severe impairment of lung function (such as FEV1 \< 40% predicted value, FVC \< 50% predicted value, DLCO \< 40% predicted value).
- High risk of skin invasion and ulceration at the puncture site before treatment.
- There is a large range of liquefaction and necrosis in the lesion, and the expected seed distribution would be poor.
- Pregnant women, lactating women and mentally ill patients.
- The patient with poor compliance and unable to complete the treatment.
- Other conditions of the researchers who think it is not suitable to participate in this clinical trial.
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Interventions
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.
Locations(1)
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NCT05351268