3D-PCT Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of Head and Neck Tumors

Recruiting

• Conditions: Malignant Tumor of Head and/or Neck
• Interventions: Radiation: Radioactive Iodine-125 Seeds Implantation

• Registration Number: NCT05421507
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The purpose of this study is to verify the accuracy, short-term efficacy and side effects of 3D printing coplanar template combined with CT-guided I-125 seeds implantation in the treatment of malignant tumors of the head and neck.

Detailed Description

Iodine-125 seeds Implantation (RISI) for the treatment of tumors, mainly with the help of imaging guidance, the radioactive I-125 seeds radioactive source is directly implanted into the tumor tissue, and the purpose of killing tumor cells is achieved through the continuous release of radiation by radionuclide. At present, it has been clinically used in the local treatment of tumors in head and neck, chest, abdomen, pelvis, spine, columns and limbs. The main technical difficulties in implementing RISI lies in the complexity of operation and the control of operation quality.In the era of unarmed puncture, the quality of operation is difficult to guarantee, and the therapeutic effect is quite different.In 2015, our unit carried out RISI technology under the guidance of 3D model plates, which significantly improved the treatment accuracy of RISI.

The current 3D printing templates are divided into two types: non-coplanar template (3D-PNCT) and coplanar template (3D-PCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of non-coplanar mold board, a considerable number of patients can be well treated with coplanar template.Compared with the non-coplanar individualized template, the coplanar template has the advantages of accurate needle path control, rapid needle path adjustment, convenient real-time optimization, batch production without waiting for template printing time, and the operation is easy to process, easy for doctors to grasp quickly, the cost is lower than non-coplanar template, and easy to carry out at the grass-roots level. However, most of the existing clinical application data of the template come from the non-coplanar template, and the dosimetry, needle path error and clinical effect of particle implantation guided by the coplanar template are still lack of research. Therefore, this study intends to explore the coplanar template technology and analyze the safety and effectiveness of 3D printing coplanar template combined with CT-guided I-125 seeds implantation in the treatment of head and neck malignant tumors.

The purpose of this study is to verify the accuracy, short-term efficacy and side effects of 3D printing coplanar template combined with CT-guided I-125 seeds implantation in the treatment of malignant tumors of the head and neck.

Study Timeline

• Study First Submitted: 2022-05-24
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-12
• Study First Posted: 2022-06-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2024-05-28
• Study Completion: 2026-05-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• the age is 18-80 years old;
• the pathological diagnosis is clear, patients with local recurrence / metastasis of head and neck tumor after operation or external radiotherapy;
• the tumor diameter ≤ 5cm, the number of lesions ≤ 3;
• there is a suitable puncture path, and the target dose of pre can reach the prescribed dose;
• KPS ≥ 70 points, the expected survival time is more than 3 months;
• patients have signed a consent form for I-125 seeds implantation therapy;
• patients have signed the consent form of knowing emotions to participate in this observational study;

Exclusion Criteria

• coagulation dysfunction;
• tumor surface rupture, or tumor memory liquefied and necrotic in a large range, with poor expected particle distribution;
• severe underlying diseases, resulting in unsafe completion of I-125 seeds implantation therapy, including active infections requiring drug treatment;
• mental abnormalities affecting cognitive ability;
• poor compliance and inability to complete treatment;
• those who were considered unsuitable to participate in this clinical trial;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with head and neck tumors with local recurrence or metastasis	Radioactive Iodine-125 Seeds Implantation	The patients in the group were treated with routine clinical treatment: 3D-PCT combined with CT-guided I-125 seeds implantation in the treatment of head and neck malignant tumors. The prescription dose is given 110-150Gy according to tumor pathological type, tumor volume, history of previous radiotherapy and different surrounding normal tissues according to experience and routine diagnosis and treatment.

Primary Outcome Measures

Name	Time	Method
Adverse events(operation-related complications and radiation side effects)	The side effects were completely observed after 2 years of follow-up.The follow-up interval was calculated from the completion of the treatment, once every 3 months in the first year and once every 6 months in the second year.	Adverse events are commonly used in the term v5.0 to evaluate the side effects after treatment. The evaluation organ depends on the specific condition of the treatment site and the tissue adjacent to the target area. Other adverse events included particle displacement, needle implantation transfer, and operation-related complications (bleeding, nerve injury, etc).

Secondary Outcome Measures

Name	Time	Method
Local progression free survival	The local progression free survival were completely observed after 2 years of follow-up.The follow-up interval was calculated from the completion of the treatment, once every 3 months in the first year and once every 6 months in the second year.	The length of time during and after the treatment of the head and neck tumors, that a patient lives with the disease but it does not get worse.
Overall survival	he overall survival were completely observed after 2 years of follow-up.The follow-up interval was calculated from the completion of the treatment, once every 3 months in the first year and once every 6 months in the second year.	Overall survival (OS) is defined as the time from follow up to death.

Trial Locations

Locations (1)

Department of Radiation Oncology of Peking university third hospital; 🇨🇳 Beijing, China