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

NCT ID: NCT05421507

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-05-28

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.

Conditions

Malignant Tumor of Head and/or Neck

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with head and neck tumors with local recurrence or metastasis

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.

Radioactive Iodine-125 Seeds Implantation

Intervention Type: RADIATION

Radioactive Iodine-125 Seeds Implantation(RISI) belongs to permanent inter-tissue brachytherapy. Guided by CT or ultrasound,radioactive I-125 seeds are implanted into tumor tissue, and radioactive I-125 continuously releases radiation to kill tumor cells.Radioactive I-125 seeds can reach a higher dose in the tumor, and the dose of the normal tissue around the tumor is lower, and the damage to the normal tissue is less while reaching the radical dose. The NCCN guidelines recommend RISI as the standard treatment for early prostate cancer. For early prostate cancer, RISI can achieve comparable efficacy as surgery, complications and side effects are lower than surgery, therefore patients can obtain better quality of life. RISI is also recommended by NCCN as one of the treatments for locally recurrent rectal cancer. Several studies have confirmed that RISI is safe and effective in the treatment of locally advanced or recurrent head and neck, chest, abdominal and retroperitoneal tumors.

Interventions

Radioactive Iodine-125 Seeds Implantation

Radioactive Iodine-125 Seeds Implantation(RISI) belongs to permanent inter-tissue brachytherapy. Guided by CT or ultrasound,radioactive I-125 seeds are implanted into tumor tissue, and radioactive I-125 continuously releases radiation to kill tumor cells.Radioactive I-125 seeds can reach a higher dose in the tumor, and the dose of the normal tissue around the tumor is lower, and the damage to the normal tissue is less while reaching the radical dose. The NCCN guidelines recommend RISI as the standard treatment for early prostate cancer. For early prostate cancer, RISI can achieve comparable efficacy as surgery, complications and side effects are lower than surgery, therefore patients can obtain better quality of life. RISI is also recommended by NCCN as one of the treatments for locally recurrent rectal cancer. Several studies have confirmed that RISI is safe and effective in the treatment of locally advanced or recurrent head and neck, chest, abdominal and retroperitoneal tumors.

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qiu Bin

Principe Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Radiation Oncology of Peking university third hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Bin Qiu

Role: primary

542122203@qq.com

01082265968

Other Identifiers

CHiECRCT20220018

Identifier Type: -

Identifier Source: org_study_id