The Clinical Value of Iodine-125 Seed Implantation in the Treatment of Iodine-refractory Differentiated Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- Adverse event
研究概览
简要总结
A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance.
详细描述
Data from RAIR-DTC patients hospitalized at Jiangxi Cancer Hospital from January 2015 to February 2022 were retrospectively collected.
In advance of the surgery, patients were informed about their condition, the expected efficacy of 125I seed implantation therapy, alternative treatments such as external beam radiotherapy and chemotherapy, as well as potential side effects and toxic effects. The preoperative evaluation process includes assessments of coagulation function, liver and kidney function, cardiopulmonary function, and local CT scans.
A collaborative effort between physicians and physicists was undertaken to establish a treatment regimen with a prescription dose ranging from 80 to 120 Gy. The patient accepted the treatment plan and signed an informed consent form. The CT-guided 125I seed implantation procedure was conducted according to the prescribed treatment regimen. Efficacy evaluations were conducted at pre-surgery, 1-, 3-, and 5-month post-surgery. The evaluations focused on lesion dimensions, serum thyroglobulin (Tg), TG antibodies (TGAb), thyroid-stimulating hormone (TSH) levels, pain levels, and adverse reactions.
Lesion size was determined using CT imaging. Lymph nodes were assessed based on their shortest diameter, while other target lesions were evaluated based on their longest diameter. Each measurable lesion underwent an average measurement derived from a minimum of three readings, with all measurements conducted by the same individual to minimize measurement discrepancies.
Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [1] were used to assess treatment response. Use the Visual Analogue Scale to record patients' pain scores. Postoperative adverse reactions, including infection, bleeding, pneumothorax, bone marrow suppression, and seed displacement, were recorded. Radiation injury was graded according to the Radiation Therapy Oncology Group (RTOG) and European Organization for Research and Treatment of Cancer (EORTC) toxicity criteria [2].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Differentiated Thyroid Cancer (DTC) was confirmed by pathology, with local recurrence or distant metastasis of residual thyroid cancer and conforming to any of the following Iodine-Refractory Differentiated Thyroid Cancer (RAIR-DTC) criteria: (1) no uptake of 131I in the initial 131I treatment; (2) loss of iodine uptake capacity in previously functional iodine-avid lesions; (3) disease progression after 131I therapy, including gradual enlargement of the lesion and continuously increasing levels of serum thyroglobulin (Tg).
排除标准
- •Patients with severe physical diseases, such as severe dysfunction of the cardiac, pulmonary, hepatic, or renal systems, poor compliance, inability to tolerate 125I seed implantation, severe acute infectious or chronic infection with acute exacerbation, severe coagulopathy that may lead to serious complications like infection or bleeding, pregnant or lactating women affecting fetal and infant growth and development, patients with cachexia or expected survival of ≤3 Months and patients with positive serum anti-thyroglobulin antibodies (TgAb) that may impact the assessment of treatment efficacy.
结局指标
主要结局
Adverse event
时间窗: Assess within six months after surgery.
Postoperative adverse reactions, including infection, bleeding, pneumothorax, bone marrow suppression, and seed displacement, were recorded. Radiation injury was graded according to the Radiation Therapy Oncology Group (RTOG) and European Organization for Research and Treatment of Cancer (EORTC) toxicity criteria \[2\].
Tumor size
时间窗: Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.
Lesion size was determined using CT imaging. Lymph nodes were assessed based on their shortest diameter, while other target lesions were evaluated based on their longest diameter. Each measurable lesion underwent an average measurement derived from a minimum of three readings, with all measurements conducted by the same individual to minimize measurement discrepancies. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) were used to assess treatment response\[1\].
Serological assessment
时间窗: Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.
Including serum thyroglobulin (Tg) and serum anti-thyroglobulin antibody levels (TgAb) in thyrotropin-inhibited states, as well as tumor markers such as CEA.
Pain score
时间窗: Patients were evaluated preoperatively and at 1, 3, and 5 months postoperatively.
Use the Visual Analogue Scale to record patients' pain scores. The scale ranges from 0 to 10 points, with pain increasing incrementally. 0 indicates no pain, 1-3 indicate mild pain that is still tolerable and does not interfere with sleep or normal life, 4-6 indicate moderate pain that interferes with sleep and requires analgesic medication to alleviate it, and 7-10 show intense and intolerable pain that seriously interferes with sleep and diet and requires strong analgesic drugs.
次要结局
未报告次要终点