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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer; Radioactive Iodine-125 Brachytherapy; 3D Printing Coplanar Template; Nuclear Radiation Effects
• Intervention / Treatment: Radiation: Radioactive seed brachytherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junjie Wang, M.D.; Phone Number: 008601082265921; Email: junjiewang_edu@sina.cn
• Study Contact Backup: Name: Zhe Ji, M.D.; Phone Number: 008618710002823; Email: aschoff@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Junjie Wang, M.D.; Phone Number: 008601082265921; Email: junjiewang_edu@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 3DPCT and CT guided RISI; All patients were treated with clinical routine treatment: 3DPCT combined with CT guided radioactive seed implantation. Collect patient information and treatment information for analysis.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BYSY-2022-3DPCT-TC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 month after the study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by the research sponsor. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No