PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors
NCT ID: NCT07327515
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2026-01-31
2028-06-01
Brief Summary
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Primary endpoints include technical success rate, dosimetric superiority, and 6-month local control. Secondary endpoints include dosimetric indices (D90, V100, conformity index, homogeneity index), pain relief, quality of life (EORTC QLQ-C30), treatment-related adverse events (CTCAE v5.0), progression-free survival (PFS), failure-free survival (FFS), and overall survival (OS). Exploratory analyses will evaluate associations between baseline PET metabolic parameters (SUVmax, metabolic tumor volume) and clinical outcomes, assess the feasibility of SUV-guided dose painting, and compare the performance of tumor-specific tracers (such as PSMA and FAPI) with FDG for target delineation and treatment response prediction.
The central hypothesis is that PET/CT-guided planning-particularly when incorporating biological dose optimization-will achieve superior dosimetric performance and improved local control and survival outcomes compared with conventional CT-guided implantation.
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Detailed Description
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Eligible participants with measurable solid tumors suitable for percutaneous implantation are assigned to one of three groups: (1) conventional CT-guided implantation, (2) PET/CT-guided implantation with standard dosing, and (3) PET/CT-guided implantation with biological dose optimization based on metabolic activity quantified by SUV measures. PET/CT is used to identify metabolically active sub-volumes for selective dose escalation while sparing normal tissues, achieved by adjusting seed activity or spatial distribution to deliver intensified irradiation to high-SUV tumor regions. In addition to standard 18F-FDG PET/CT, tumor-specific tracers are evaluated in selected subgroups to enhance lesion visualization and biological characterization, including 18F-PSMA for prostate cancer, 68Ga-FAPI for pancreatic, colorectal, and fibrotic tumors, 18F-FES for ER-positive breast cancer, and 18F-FMISO or 18F-FAZA for hypoxia detection and targeted dose escalation.
Primary endpoints include technical success rate, dosimetric superiority, and 6-month local control defined by imaging and clinical criteria. Secondary endpoints include dosimetric parameters (D90, V100, conformity index, homogeneity index), pain relief, quality of life (EORTC QLQ-C30), treatment-related adverse events (CTCAE v5.0), and time-to-event outcomes including progression-free survival (PFS), failure-free survival (FFS), and overall survival (OS). Exploratory analyses evaluate correlations between baseline PET parameters (SUVmax, metabolic tumor volume, total lesion glycolysis), radiomics features, and clinical outcomes, as well as early metabolic response (ΔSUVmax at 4-6 weeks) as a predictor of local control.
The central hypothesis is that PET/CT-guided biological optimization will enhance dosimetric conformity, improve local tumor control and survival outcomes, reduce recurrence, and contribute to better symptom relief and quality-of-life measures. Overall, the trial aims to establish a personalized, molecular-imaging-based framework for radioactive seed implantation therapy in malignant solid tumors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CT-Guided Radioactive Seed Implantation
CT-guided 125I seed brachytherapy with a standard dose prescription. Target delineation based on contrast-enhanced CT. Post-implant dosimetry will verify D90, V100, V150, and organ-at-risk constraints.
CT-Guided Radioactive Seed Implantation
CT-guided implantation of 125I radioactive seeds for localized treatment of malignant tumors. The target area is delineated on contrast-enhanced CT images, and seeds are implanted according to a treatment planning system (TPS) with a prescribed dose of about 100 Gy. Post-procedure dosimetry will confirm D90, V100, and V150, as well as organ-at-risk (OAR) dose constraints.
PET/CT-Guided Radioactive Seed Implantation - Standard Dose
PET/CT-guided 125I seed implantation using PET/CT to support anatomical target delineation without SUV-based biological sub-volume definition. A standard uniform-dose prescription is applied. Post-implant dosimetry verifies target coverage and organ-at-risk constraints.
PET/CT-Guided Radioactive Seed Implantation
PET/CT-guided 125I seed implantation performed using PET/CT fusion to support anatomical target delineation without SUV-based biological sub-volume definition. A standard uniform-dose treatment plan is implemented, and post-implant dosimetric evaluation is used to confirm target coverage and compliance with organ-at-risk constraints.
PET/CT-Guided Radioactive Seed Implantation - Biological Dose Optimization
PET/CT-guided 125I seed implantation incorporating SUV-based biological sub-volume identification. High-SUV regions receive selective dose escalation through adjustments in seed activity or spatial seed distribution while maintaining organ-at-risk constraints.
PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization)
PET/CT-guided 125I seed implantation for the treatment of malignant tumors. The biological target volume (BTV) is defined using 18F-FDG PET/CT fused with planning CT to improve target accuracy and tumor coverage. The prescribed dose is approximately 100 Gy. Post-implant verification includes D90, V100, and OAR constraints.
Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup)
Tumor-specific PET tracers such as PSMA and FAPI are used in selected subgroups to enhance lesion visualization and biological characterization for planning 125I seed implantation. Additional tracers are not currently in clinical use within the department but may be incorporated in future protocol amendments as availability allows.
Tumor-Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup)
125I seed brachytherapy guided by tumor-specific PET/CT imaging. Tracers such as PSMA (for prostate cancer) and FAPI (for pancreatic, colorectal, and fibrotic tumors) identify biologically active regions for targeted dose escalation. High-uptake areas (SUVmax \> threshold determined by tracer characteristics) receive escalated doses of approximately 120-150 Gy through increased seed density or activity, while normal tissues remain within tolerance limits.
Interventions
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PET/CT-Guided Radioactive Seed Implantation
PET/CT-guided 125I seed implantation performed using PET/CT fusion to support anatomical target delineation without SUV-based biological sub-volume definition. A standard uniform-dose treatment plan is implemented, and post-implant dosimetric evaluation is used to confirm target coverage and compliance with organ-at-risk constraints.
PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization)
PET/CT-guided 125I seed implantation for the treatment of malignant tumors. The biological target volume (BTV) is defined using 18F-FDG PET/CT fused with planning CT to improve target accuracy and tumor coverage. The prescribed dose is approximately 100 Gy. Post-implant verification includes D90, V100, and OAR constraints.
CT-Guided Radioactive Seed Implantation
CT-guided implantation of 125I radioactive seeds for localized treatment of malignant tumors. The target area is delineated on contrast-enhanced CT images, and seeds are implanted according to a treatment planning system (TPS) with a prescribed dose of about 100 Gy. Post-procedure dosimetry will confirm D90, V100, and V150, as well as organ-at-risk (OAR) dose constraints.
Tumor-Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup)
125I seed brachytherapy guided by tumor-specific PET/CT imaging. Tracers such as PSMA (for prostate cancer) and FAPI (for pancreatic, colorectal, and fibrotic tumors) identify biologically active regions for targeted dose escalation. High-uptake areas (SUVmax \> threshold determined by tracer characteristics) receive escalated doses of approximately 120-150 Gy through increased seed density or activity, while normal tissues remain within tolerance limits.
Eligibility Criteria
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Inclusion Criteria
2. Pathologically or clinically confirmed malignant tumor (solid tumor, lymphoma, or leukemia with a localized lesion suitable for radioactive seed implantation).
3. Tumor site accessible for image-guided implantation, with a target lesion visible on CT or PET/CT.
4. Life expectancy of at least 6 months.
5. Ability to undergo PET/CT imaging (FDG or tumor-specific tracers such as PSMA or FAPI).
6. Signed written informed consent.
Exclusion Criteria
2. Uncontrolled infection or active systemic inflammatory disease.
3. Severe cardiopulmonary dysfunction that contraindicates interventional procedures (e.g., heart failure, severe COPD).
4. Coagulation disorders (INR \> 1.5 or platelet count \< 50 × 10⁹/L).
5. Known allergy or intolerance to radiopharmaceuticals or iodinated contrast media.
6. Prior radiation therapy overlapping with the planned implantation area.
7. Participation in another clinical trial within the past 30 days that may interfere with study results.
8. Any medical or psychosocial condition considered unsuitable for study participation by the investigators (e.g., poor compliance, unstable clinical status).
18 Years
ALL
No
Sponsors
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Li Min
OTHER
Responsible Party
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Li Min
Vice Director
Principal Investigators
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Min Li, Dr.
Role: STUDY_DIRECTOR
Locations
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The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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960HP20251026
Identifier Type: -
Identifier Source: org_study_id
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