Clinical trial · Observational
3D-PCT Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of 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
NCT05421507CI-TRIAL-00059735unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Head and/or Neck | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radioactive Iodine-125 Seeds Implantation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with head and neck tumors with local recurrence or metastasis
- description
- 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.
- interventionNames
- Radiation: Radioactive Iodine-125 Seeds Implantation
Primary outcomes (1)
- measure
- Adverse events(operation-related complications and radiation side effects)
- timeFrame
- 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.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.