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Completed

NCT Number: NCT07208487

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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

Exclusion criteria

(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.

Treatment and study plan

Primary outcomes

  1. Tumor size

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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