Status:
RECRUITING
3D-PCT Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of Head and Neck Tumors
Lead Sponsor:
Peking University Third Hospital
Conditions:
Malignant Tumor of Head and/or Neck
Eligibility:
All Genders
18-80 years
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 malignan...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 28 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05421507
Start Date
June 1 2022
End Date
May 28 2026
Last Update
July 20 2022
Active Locations (1)
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1
Department of Radiation Oncology of Peking university third hospital
Beijing, China