[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618122":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":48,"centralContacts":52,"locations":59,"responsibleParty":75,"collaborators":35,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":35,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":35,"enrollmentInfo":88,"targetDuration":35,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":102,"whyStopped":35,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Jinan Military General Hospital","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: CT-Guided Radioactive Seed Implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"PET\u002FCT-Guided Radioactive Seed Implantation - Standard Dose","EXPERIMENTAL","PET\u002FCT-guided 125I seed implantation using PET\u002FCT 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.",[19],"Procedure: PET\u002FCT-Guided Radioactive Seed Implantation",{"label":21,"type":16,"description":22,"interventionNames":23},"PET\u002FCT-Guided Radioactive Seed Implantation - Biological Dose Optimization","PET\u002FCT-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.",[24],"Procedure: PET\u002FCT-Guided Radioactive Seed Implantation (Biological Dose Optimization)",{"label":26,"type":16,"description":27,"interventionNames":28},"Specific PET\u002FCT-Guided Radioactive Seed Implantation (PSMA\u002FFAPI 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.",[29],"Procedure: Tumor-Specific PET\u002FCT-Guided Radioactive Seed Implantation (PSMA\u002FFAPI Subgroup)",[31,36,40,44],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","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.",[9],null,{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"PET\u002FCT-Guided Radioactive Seed Implantation","PET\u002FCT-guided 125I seed implantation performed using PET\u002FCT 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.",[15],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"PET\u002FCT-Guided Radioactive Seed Implantation (Biological Dose Optimization)","PET\u002FCT-guided 125I seed implantation for the treatment of malignant tumors. The biological target volume (BTV) is defined using 18F-FDG PET\u002FCT 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.",[21],{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Tumor-Specific PET\u002FCT-Guided Radioactive Seed Implantation (PSMA\u002FFAPI Subgroup)","125I seed brachytherapy guided by tumor-specific PET\u002FCT 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.",[26],[49],{"name":50,"affiliation":35,"role":51},"Min Li, Dr.","STUDY_DIRECTOR",[53,57],{"name":50,"role":54,"phone":55,"phoneExt":35,"email":56},"CONTACT","0531-51665482","liminyingxiang@163.com",{"name":50,"role":54,"phone":35,"phoneExt":35,"email":58},"924787237@qq.com",[60],{"facility":61,"status":35,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"The 960th Hospital of People's Liberation Army (PLA)","Jinan","Shandong","250031","China","CN",{"type":68,"coordinates":69},"Point",[70,71],116.99722,36.66833,{"lat":71,"lon":70},[74],{"name":50,"role":54,"phone":55,"phoneExt":35,"email":58},{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Li Min","Vice Director","100618122","petct-guided-biological-target-volume-delineation-and-dose-optimization-for-radioactive-seed-implantation-therapy-in-malignant-tumors-100618122",false,"NCT07327515","PET\u002FCT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors","A Phase I\u002FII Study of PET\u002FCT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Pathologically or clinically confirmed malignant tumor (solid tumor, lymphoma, or leukemia with a localized lesion suitable for radioactive seed implantation).\n3. Tumor site accessible for image-guided implantation, with a target lesion visible on CT or PET\u002FCT.\n4. Life expectancy of at least 6 months.\n5. Ability to undergo PET\u002FCT imaging (FDG or tumor-specific tracers such as PSMA or FAPI).\n6. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Uncontrolled infection or active systemic inflammatory disease.\n3. Severe cardiopulmonary dysfunction that contraindicates interventional procedures (e.g., heart failure, severe COPD).\n4. Coagulation disorders (INR \\> 1.5 or platelet count \\\u003C 50 × 10⁹\u002FL).\n5. Known allergy or intolerance to radiopharmaceuticals or iodinated contrast media.\n6. Prior radiation therapy overlapping with the planned implantation area.\n7. Participation in another clinical trial within the past 30 days that may interfere with study results.\n8. Any medical or psychosocial condition considered unsuitable for study participation by the investigators (e.g., poor compliance, unstable clinical status).","ALL","18 Years",{"count":89,"type":90},90,"ESTIMATED","INTERVENTIONAL",[93],"NA","This prospective, open-label Phase I\u002FII trial evaluates a PET\u002FCT-guided planning strategy for radioactive seed implantation therapy in malignant solid tumors. The approach integrates metabolic information from PET\u002FCT 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\u002FCT-guided standard-dose implantation, or PET\u002FCT-guided biologically optimized implantation. All participants undergo image-guided treatment followed by post-implant dosimetric verification and standardized clinical follow-up.\n\nPrimary 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.\n\nThe central hypothesis is that PET\u002FCT-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.",[96],"Malignant Tumors",[98,99,100,101],"PET\u002FCT-Guided Brachytherapy","Iodine-125 Seed Implantation","Molecular Imaging-Guided Therapy","Biology-Guided Dose Planning","NOT_YET_RECRUITING","2026-01-02",{"date":105,"type":106},"2026-01-08","ACTUAL",{"date":108,"type":90},"2026-01",{"date":110,"type":90},"2028-06-01",{"name":77,"class":6},1]