Using 3D printing and radioactive seeds to treat head and neck tumors

A Serial Case, Single-arm, Real-world Study of the Safety and Efficacy of 3D-printed Coplanar Template Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of Head and Neck Tumors

This study is testing if using 3D-printed templates to help place radioactive seeds directly into head and neck tumors can make treatment more accurate and effective for patients with cancer.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT05421507 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the accuracy, short-term effectiveness, and side effects of using a 3D-printed coplanar template combined with CT-guided implantation of iodine-125 seeds for treating malignant tumors in the head and neck. The iodine-125 seeds are directly implanted into the tumor tissue, releasing radiation to kill cancer cells. The study focuses on improving treatment precision and operational quality by utilizing 3D printing technology to create templates that facilitate accurate needle placement during the procedure.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with a clear pathological diagnosis of local recurrence or metastasis of head and neck tumors, having tumors no larger than 5 cm and a performance status score of 70 or higher.

Not a fit: Patients with coagulation dysfunction, severe underlying diseases, or those whose tumors are not suitable for implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of localized treatment for head and neck tumors, potentially leading to better patient outcomes.

How similar studies have performed: Previous studies have shown promise in using similar techniques for tumor treatment, but this specific approach with 3D-printed templates is relatively novel.

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;

Where this trial is running

Beijing

• Department of Radiation Oncology of Peking university third hospital — Beijing, China (Recruiting)

Conditions Malignant Tumor of Head and/or Neck; iodine-125 seeds implantation; 3D printing non co-planar template