Implanting I-125 seeds to treat recurrent lung cancer after radiotherapy
Safety and Efficacy of 3D-printing Template Assisted CT-guided Radioactive I-125 Seeds Implantation in the Treatment of Recurrent Lung Cancer After External Beam Radiotherapy: a Multicenter, Prospective Cohort Study
This study is testing whether implanting tiny radioactive seeds can help patients with recurrent lung cancer feel better after they've already had radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04071418 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of radioactive I-125 seed implantation in patients with recurrent non-small cell lung cancer (NSCLC) following radiotherapy. It focuses on patients who have local recurrence without distant metastasis and assesses the relationship between treatment doses and outcomes. The study plans to enroll 30 patients and will utilize a 3D-printing template for precise CT-guided implantation of the seeds. The goal is to achieve a high dose of radiation directly to the tumor while minimizing exposure to surrounding healthy tissue.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with recurrent NSCLC after radiotherapy, a tumor diameter of less than 5 cm, and no systemic metastasis.
Not a fit: Patients with severe pulmonary dysfunction or significant underlying health issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new local therapy option for patients with recurrent lung cancer who have limited treatment choices.
How similar studies have performed: Previous studies on I-125 seed implantation for NSCLC have shown promising local control rates, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Age 18-75 years old * (2) Pathological diagnosis of NSCLC, recurrence after radiotherapy, lesion diameter less than 5 cm * (3) No systemic metastasis or metastasis, metastasis has been controlled by pre-treatment * (4) No bleeding tendency, anticoagulant therapy and/or anti-platelet coagulant drugs should be stopped for at least one week before seed implantation * (5) No serious or uncontrolled underlying diseases (such as severe or uncontrolled high). Blood pressure, diabetes mellitus, cardiovascular and cerebrovascular diseases and organ dysfunction, etc. * (6) There is a suitable puncture path, which is expected to achieve the therapeutic dose * (7) KPS \> 70 points, which is expected to be able to tolerate puncture/RISI therapy, and the expected survival time is longer than 3 months. Exclusion Criteria: * (1) Poor basic pulmonary function with severe emphysema, bullae and interstitial pneumonia * (2) Liquefaction and necrosis in a large area near the mediastinum or focus, with high risk of puncture bleeding or poor seeds distribution * (3) Infection and ulcer in puncture site * (4) Pregnant women, lactating women, children and psychiatric patients * (5) Patients who are participating in other clinical studies * (6) Poor compliance, unable to complete the treatment * (7) The researchers think that it is not appropriate to participate in this clinical trial
Where this trial is running
Beijing, Beijing
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Junjie Wang, M.D. Ph.D. — Department of Radiation Oncology, Peking University Third Hospital
- Study coordinator: Zhe Ji, M.D.
- Email: aschoff@163.com
- Phone: 008618710002823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.