Clinical trial · Observational
Clinical Study of Pretreatment PET/CT Parameters for Predicting the Efficacy of 125I Seed Implantation in the Treatment of Malignant Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 125I seed implantation treatment group
- description
- Inform the patient of relevant precautions and obtain signed informed consent. Upload CT data in DICOM format to the TPS system. Contour the tumor target volume and critical organs layer by layer. Design the needle insertion direction, angle, and depth. Determine the prescribed dose, number of implants, and activity. Obtain the Dose and Volume Histogram (DVH). For patients without prior external beam radiotherapy, the prescribed dose is 120 Gy. For those with prior external beam radiotherapy, the prescribed dose ranges from 80 to 100 Gy, ensuring surrounding critical organs receive doses within safe limits. Position, immobilize, disinfect, and drape the patient according to surgical positioning. After instructing the patient to hold their breath, perform CT scanning for localization. Following local anesthesia, complete particle implantation according to the preoperative plan. After particle implantation, perform another CT scan to verify dose distribution.
Primary outcomes (1)
- measure
- Tumor size
- timeFrame
- 4 months post-surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- RESULTWatanabe H, Okada M, Kaji Y, Satouchi M, Sato Y, Yamabe Y, Onaya H, Endo M, Sone M, Arai Y. [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. Gan To Kagaku Ryoho. 2009 Dec;36(13):2495-501. Japanese. PMID 20009446