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临床试验/NCT07208487
NCT07208487已完成不适用

Clinical Study of Pretreatment PET/CT Parameters for Predicting the Efficacy of 125I Seed Implantation in the Treatment of Malignant Tumors

Jiangxi Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Tumor size

研究概览

简要总结

This study aimed to determine if pre-treatment 18F-FDG PET/CT metabolic parameters could predict the effectiveness of 125I seed implantation for malignant tumors. In a retrospective analysis of 41 patients with 69 lesions, various parameters were measured. The results identified Metabolic Tumor Volume (MTV) as the most significant independent prognostic factor, outperforming other standardized uptake values (SUV) and ratios. A higher MTV was associated with a worse treatment outcome, suggesting it is a valuable predictor for guiding treatment decisions.

详细描述

Objective The purpose of the research is to assess the role of pretreatment 18F-FDG PET/CT parameters in predicting the efficacy of 125I seed implantation in the treatment of malignant tumors, in order to allow for timely clinical interventions and adjustments in the treatment regimen. Methods A retrospective analysis was made on patients who were treated with 125I seed implantation for malignant tumors and underwent 18F-FDG PET/CT before treatment from November 2019 to November 2023 in our hospital. The clinical data of 41 patients with 69 lesions were collected completely, including age, gender, primary tumor and seed implantation sites. Metabolic parameters including TLG, MTV, SUVmax-bw, SUVmax-bsa, SUVmax-lbm, SUVmean-bw, SUVmean-bsa, SUVmean-lbm, SUVpeak-bw, SUVpeak-bsa, SUVpeak-lbm, TLR, TLMR, TBR and TBMR were measured at pretreatment PET/CT. The patients were followed up at 4 months after the procedure by CT scans. The efficacy of response was evaluated by using the response evaluation criteria in solid tumors (RECIST1.1). Results The area under the curves for TLG and MTV were 0.815 (P<0.001) and 0.804 (P<0.001) respectively. Univariate logistic regression analysis and multivariate logistic regression analysis. The results showed that only the MTV (OR: 6.477, 95%CI: 1.157-36.271, P=0.034) was an independent prognostic factor for the efficacy of 125I seed implantation for malignant tumors. Conclusion In patients with malignant tumors treated with 125I seed implantation, the 18F-FDG PET/CT parameters MTV in the prediction of the efficacy was superior to SUVmax, SUVmean and SUVpeak which normalized by body weight, body surface area and lean body mass, as well as to TLR, TLMR, TBR and TBMR. The 18F-FDG PET/CT parameter MTV was an independent prognostic factor for the efficacy of 125I seed implantation in the treatment of malignant tumors.

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

入选标准

  • (1) Interval between PET/CT imaging and 125I seed implantation ≤4 weeks; (2)CT follow-up performed 4 months post-125I seed implantation; (3) Primary tumor pathologically or cytologically diagnosed as malignant; (4) Metastatic or recurrent lesions implanted with 125I confirmed by cytological aspiration or imaging

排除标准

  • (1) Lesions too small or SUVmax < 2.5, rendering them unidentifiable by software for PET/CT parameter measurement; (2) Two 125I seed implantation procedures performed within 6 months for the same lesion; (3) Incomplete clinical or imaging data.

结局指标

主要结局

Tumor size

时间窗: 4 months post-surgery

Referencing the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), efficacy is categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression Disease (PD). Objective response rate (ORR) was defined as the proportion of lesions achieving CR or PR, while non-ORR was defined as the proportion of lesions achieving SD or PD.

次要结局

未报告次要终点

研究者

发起方
Jiangxi Provincial Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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