Malignant TumorsNCT07327515
PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors
A study testing CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation and PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization) in people with Malignant Tumors, run by Li Min at 1 site in China.
Trial summary
This prospective, open-label Phase I/II trial evaluates a PET/CT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors. The approach integrates metabolic information from PET/CT into brachytherapy planning to improve the accuracy of biological target volume delineation, enhance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation and PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Pathologically or clinically confirmed malignant tumor (solid tumor, lymphoma, or leukemia with a localized lesion suitable for radioactive seed implantation).
- Tumor site accessible for image-guided implantation, with a target lesion visible on CT or PET/CT.
- Life expectancy of at least 6 months.
- Ability to undergo PET/CT imaging (FDG or tumor-specific tracers such as PSMA or FAPI).
- Signed written informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Uncontrolled infection or active systemic inflammatory disease.
- Severe cardiopulmonary dysfunction that contraindicates interventional procedures (e.g., heart failure, severe COPD).
- Coagulation disorders (INR > 1.5 or platelet count < 50 × 10⁹/L).
- Known allergy or intolerance to radiopharmaceuticals or iodinated contrast media.
- Prior radiation therapy overlapping with the planned implantation area.
- Participation in another clinical trial within the past 30 days that may interfere with study results.
- Any medical or psychosocial condition considered unsuitable for study participation by the investigators (e.g., poor compliance, unstable clinical status).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Min Li, Dr. contact
China1 site
The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, 250031
Min Li, Dr., 0531-51665482, 924787237@qq.com
About this study
Official title: A Phase I/II Study of PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors
This prospective, open-label Phase I/II trial evaluates a PET/CT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors. The approach integrates metabolic information from PET/CT into brachytherapy planning to improve the accuracy of biological target volume delineation, enhance dose coverage, and support biologically informed dose delivery. Eligible participants are assigned to one of three arms: conventional CT-guided implantation, PET/CT-guided standard-dose implantation, or PET/CT-guided biologically optimized implantation. All participants undergo image-guided treatment followed by post-implant dosimetric verification and standardized clinical follow-up.
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.
Read the detailed description
This prospective, open-label Phase I/II trial evaluates a molecular-imaging-guided optimization strategy that integrates PET/CT into radioactive seed implantation therapy to improve target delineation accuracy, biological precision, and therapeutic efficacy in malignant solid tumors. Conventional CT-guided planning relies primarily on anatomical visualization and geometric dose coverage but does not incorporate intratumoral biological heterogeneity, which may result in uneven dose distribution and increased risk of local recurrence. To address this limitation, the trial incorporates PET/CT-based biological target volume (BTV) delineation and standardized uptake value (SUV)-driven dose modulation to achieve individualized, biologically optimized treatment planning.
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
- Malignant Tumors
- Being tested
- CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization), Tumor-Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup)
- Keywords
- PET/CT-Guided Brachytherapy, Iodine-125 Seed Implantation, Molecular Imaging-Guided Therapy, Biology-Guided Dose Planning
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Guided Radioactive Seed ImplantationProcedure or surgery
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 ImplantationProcedure or surgery
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)Procedure or surgery
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.
Tumor-Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CT-Guided Radioactive Seed Implantation | Active comparator | 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. Receives: Procedure: CT-Guided Radioactive Seed Implantation |
| PET/CT-Guided Radioactive Seed Implantation - Standard Dose | Experimental | 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. Receives: Procedure: PET/CT-Guided Radioactive Seed Implantation |
| PET/CT-Guided Radioactive Seed Implantation - Biological Dose Optimization | Experimental | 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. Receives: Procedure: PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization) |
| Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup) | Experimental | 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. Receives: Procedure: Tumor-Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate
Technical success is defined as post-implant dosimetry achieving D90 ≥ 90 Gy and V100 ≥ 85% without major intraoperative or immediate postoperative complications (CTCAE Grade ≥3).
Measured: Within 24 hours after procedure
Dosimetric Superiority of PET/CT-Guided Implantation
Comparison of mean D90 between PET/CT-guided and CT-guided groups. Superiority is defined as a ≥10 Gy improvement in D90 or ≥5% increase in V100 coverage.
Measured: Immediately after implantation (dosimetric verification)
Local Control Rate at 6 Months
Local control is defined as complete response, partial response, or stable disease per RECIST 1.1 criteria at treated sites on follow-up imaging.
Measured: 6 months ± 2 weeks after implantation
Secondary outcomes (6)
Progression-Free Survival (PFS)
Time interval from treatment to progression or death, analyzed using Kaplan-Meier curves and log-rank test.
Measured: From the date of implantation until documented disease progression or death, whichever occurs first, assessed for up to 24 months
Failure-Free Survival (FFS)
Time from treatment initiation to the first occurrence of disease progression, death from any cause, treatment discontinuation due to toxicity, recurrence, or initiation of new anticancer therapy.
Measured: From the date of implantation until the first documented treatment failure or death, assessed for up to 24 months
Overall Survival (OS)
Time from implantation to death from any cause, evaluated by Kaplan-Meier method.
Measured: From implantation until death from any cause, assessed for up to 24 months
Pain Relief Rate
Pain relief rate is defined as the proportion of patients achieving a clinically meaningful reduction in pain intensity, defined as either a ≥2-point absolute decrease or a ≥30% relative decrease from baseline, as assessed by the Visual Analogue Scale (VAS). The VAS is a 0-10 numeric pain rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable; higher scores indicate worse pain intensity.
Measured: Baseline, 1, 3, and 6 months post-treatment
Quality of Life (QoL)
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores on functioning scales and global health status indicate better outcomes, while higher scores on symptom scales indicate worse symptoms.
Measured: Baseline, and 6 months
Treatment-Related Adverse Events
Treatment-related adverse events will be assessed by recording the incidence, type, and severity of adverse events occurring after treatment. All adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From treatment initiation through 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startJan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned in parallel to three groups: CT-guided, PET/CT-guided standard dose, and PET/CT-guided biological dose optimization. Exploratory cohorts may use tumor-specific PET tracers, including PSMA, FAPI, and other emerging agents, to refine biological targeting and predictive modeling.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Min, Jinan Military General Hospital
- Investigators
- Min Li, Dr., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327515
- Sponsor's protocol ID
- 960HP20251026
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline demographics, PET/CT imaging parameters (SUVmax, MTV, TLG), dosimetric results, and clinical outcomes (local control, PFS, FFS, OS), will be shared upon reasonable request after publication of the main study results. Data will be available for qualified researchers conducting methodologically sound studies related to radiomics, brachytherapy, or PET-guided radiation optimization. Requests should be submitted to the principal investigator via institutional contact email. Access will require a data sharing agreement to ensure patient privacy and compliance with institutional and ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors
- ClinicalTrials.gov ID
- NCT07327515
- Acronym / sponsor ID
- 960HP20251026
- Conditions
- Malignant Tumors
- Keywords
- PET/CT-Guided Brachytherapy, Iodine-125 Seed Implantation, Molecular Imaging-Guided Therapy, Biology-Guided Dose Planning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, open-label Phase I/II trial evaluates a PET/CT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors. The approach integrates metabolic information from PET/CT into brachytherapy planning to improve the accuracy of biological target volume delineation, enhance dose coverage, and support biologically informed dose delivery. Eligible participants are assigned to one of three arms: conventional CT-guided implantation, PET/CT-guided standard-dose implantation, or PET/CT-guided biologically optimized implantation. All participants undergo image-guided treatment followed by post-implant dosimetric verification and standardized clinical follow-up.
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.
Detailed description
This prospective, open-label Phase I/II trial evaluates a molecular-imaging-guided optimization strategy that integrates PET/CT into radioactive seed implantation therapy to improve target delineation accuracy, biological precision, and therapeutic efficacy in malignant solid tumors. Conventional CT-guided planning relies primarily on anatomical visualization and geometric dose coverage but does not incorporate intratumoral biological heterogeneity, which may result in uneven dose distribution and increased risk of local recurrence. To address this limitation, the trial incorporates PET/CT-based biological target volume (BTV) delineation and standardized uptake value (SUV)-driven dose modulation to achieve individualized, biologically optimized treatment planning.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are assigned in parallel to three groups: CT-guided, PET/CT-guided standard dose, and PET/CT-guided biological dose optimization. Exploratory cohorts may use tumor-specific PET tracers, including PSMA, FAPI, and other emerging agents, to refine biological targeting and predictive modeling.
| Arm | Type | Receives |
|---|---|---|
| CT-Guided Radioactive Seed Implantation | Active comparator | Procedure: CT-Guided Radioactive Seed ImplantationCT-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. |
| PET/CT-Guided Radioactive Seed Implantation - Standard Dose | Experimental | Procedure: PET/CT-Guided Radioactive Seed ImplantationPET/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 - Biological Dose Optimization | Experimental | Procedure: 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. |
| Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup) | Experimental | Procedure: Tumor-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Pathologically or clinically confirmed malignant tumor (solid tumor, lymphoma, or leukemia with a localized lesion suitable for radioactive seed implantation).
- Tumor site accessible for image-guided implantation, with a target lesion visible on CT or PET/CT.
- Life expectancy of at least 6 months.
- Ability to undergo PET/CT imaging (FDG or tumor-specific tracers such as PSMA or FAPI).
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women.
- Uncontrolled infection or active systemic inflammatory disease.
- Severe cardiopulmonary dysfunction that contraindicates interventional procedures (e.g., heart failure, severe COPD).
- Coagulation disorders (INR > 1.5 or platelet count < 50 × 10⁹/L).
- Known allergy or intolerance to radiopharmaceuticals or iodinated contrast media.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-Guided Radioactive Seed ImplantationCT-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. | Procedure or surgery | CT-Guided Radioactive Seed Implantation |
| PET/CT-Guided Radioactive Seed ImplantationPET/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. | Procedure or surgery | PET/CT-Guided Radioactive Seed Implantation - Standard Dose |
| 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. | Procedure or surgery | PET/CT-Guided Radioactive Seed Implantation - Biological Dose Optimization |
| 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. | Procedure or surgery | Specific PET/CT-Guided Radioactive Seed Implantation (PSMA/FAPI Subgroup) |
Primary outcome
Technical Success Rate
Time frame: Within 24 hours after procedure
Technical success is defined as post-implant dosimetry achieving D90 ≥ 90 Gy and V100 ≥ 85% without major intraoperative or immediate postoperative complications (CTCAE Grade ≥3).
Dosimetric Superiority of PET/CT-Guided Implantation
Time frame: Immediately after implantation (dosimetric verification)
Comparison of mean D90 between PET/CT-guided and CT-guided groups. Superiority is defined as a ≥10 Gy improvement in D90 or ≥5% increase in V100 coverage.
Local Control Rate at 6 Months
Time frame: 6 months ± 2 weeks after implantation
Local control is defined as complete response, partial response, or stable disease per RECIST 1.1 criteria at treated sites on follow-up imaging.
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the date of implantation until documented disease progression or death, whichever occurs first, assessed for up to 24 months
Failure-Free Survival (FFS)
Time frame: From the date of implantation until the first documented treatment failure or death, assessed for up to 24 months
Overall Survival (OS)
Time frame: From implantation until death from any cause, assessed for up to 24 months
Pain Relief Rate
Time frame: Baseline, 1, 3, and 6 months post-treatment
Quality of Life (QoL)
Time frame: Baseline, and 6 months
Treatment-Related Adverse Events
Time frame: From treatment initiation through 12 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline demographics, PET/CT imaging parameters (SUVmax, MTV, TLG), dosimetric results, and clinical outcomes (local control, PFS, FFS, OS), will be shared upon reasonable request after publication of the main study results. Data will be available for qualified researchers conducting methodologically sound studies related to radiomics, brachytherapy, or PET-guided radiation optimization. Requests should be submitted to the principal investigator via institutional contact email. Access will require a data sharing agreement to ensure patient privacy and compliance with institutional and ethical standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Li, Dr. contact
Min Li, Dr. study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-Guided Radioactive Seed Implantation, PET/CT-Guided Radioactive Seed Implantation and PET/CT-Guided Radioactive Seed Implantation (Biological Dose Optimization) in people with Malignant Tumors, run by Li Min at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Li, Dr. (0531-51665482, liminyingxiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate (time frame: Within 24 hours after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.