[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-metastases-in-subjects-with-advanced-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-metastases-in-subjects-with-advanced-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,82,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100608137","phase-1-samarium-optimized-for-long-lasting-analgesia-in-cancerous-end-stage-bone-pain-100608137",false,"NCT07197645","Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain","A Phase 1 Pharmacokinetic, Dosimetry, Safety, and Dose Optimization Study for a Single Dose of TLX090-Tx (153SmDOTMP) to Treat Metastatic Bone Pain","SOLACE","Inclusion Criteria:\n\n* Participants have had disease progression while on anti-cancer treatment, and are not eligible for the treatments, or their lesions are not amenable to palliative EBRT.\n* Participants must have a histologically confirmed diagnosis of malignancy at any time prior to their participation in this clinical trial with multiple metastatic bone lesions with at least 1 metastatic painful osteoblastic tumor that causes a minimum pain score of 4 on the NRS11.\n* Participants must have bone cancer in one or more skeletal locations as identified by a 99mTc-diphosphonate bone scan within 60 days of dosing. At least one lesion must be osteoblastic. If described as osteosclerotic, radiology confirmation that the lesion is osteoblastic is required. Adequate organ function, including:\n* Renal function, defined as a measured creatinine clearance (CrCl) ≥30 mL\u002Fmin as per Cockroft Gault or based on radioisotope glomerular filtration rate (GFR).\n* Hematologic function, defined as a platelet count of \\>100,000 cells\u002Fmm3 and an Absolute neutrophil count (ANC) of \\>1000 cells\u002Fmm3.\n* Hemoglobin ≥8 g\u002FdL.\n* Liver function:\n* Total bilirubin ≤1.5 × the upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 × ULN with participants with known liver metastases.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN with participants with Gilbert's Syndrome.\n* Life expectancy of at least 16 weeks from the date of study drug administration (Day 1).\n* Karnofsky performance status \\>60%, assessed during the screening period prior to study drug administration.\n\nExclusion Criteria:\n\n* Participants are pregnant or breastfeeding.\n* Participants who have received maximum tolerable radiation to the spinal cord, have untreated pathologic bone fracture, spinal cord compression, unstable spine, or imminent long bone fracture.\n* Participants with a bone scan pattern showing diffuse, intense skeletal uptake with absent or faint kidney \u002F bladder activity, typically indicating widespread bone metastases or high bone turnover from metabolic or hematologic diseases (Superscan) pattern on Technetium 99-m bone scan scintigraphy - defined as diffusely increased skeletal uptake with absent or markedly reduced renal and soft tissue visualization - are excluded from the study.\n* Participants with impending or suspected or at high risk for spinal cord compression.\n* Participants with neurogenic pain or significant pain associated with soft tissue lesions or other pain that, in the opinion of the Investigator, might interfere with the assessment of pain relief for bone tumors.\n* Participants who require surgery over their trial period that would require pain medication or analgesia.\n* Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.\n* History of unstable angina (defined as angina at rest) or new-onset angina diagnosed within the 3 months prior to screening.\n* History of myocardial infarction within 3 months prior to screening, as determined by medical history \u002F Baseline ECG.\n* Uncontrolled cardiac arrhythmias (≥Grade 3 CTCAE version 5.0) or any history of ≥Grade 3 arrhythmia.\n* Congestive heart failure ≥New York Heart Association Class 2.\n* Clinically significant abnormalities on ECG at screening including corrected QT interval (Fridericia's formula) \\>450 msec for males or 470 msec for females at screening.\n* Inability to complete the needed investigational and standard imaging examinations due to any reason (eg, severe claustrophobia, inability to lie still for the entire imaging time).\n* Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study Investigator, would make the participant inappropriate for entry into the study.\n* Participants with active infections (human immunodeficiency virus, human papillomavirus. Hepatitis A, Hepatitis B, and Hepatitis C).","ALL","18 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open label, 2-part early phase study designed to evaluate the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of TLX090-Tx in patients with painful bone metastases.",[27,28,29],"Bone Pain","Metastatic Bone Tumor","Bone Metastases in Subjects With Advanced Cancer",[31,32,33,34,35,36,37],"samarium","radioligand","radioisotope","metastatic bone pain palliation","Samarium-153","DOTMP","bone-seeking radiopharmaceutical","RECRUITING","2026-05-12",{"date":41,"type":42},"2026-05-14","ACTUAL",{"date":44,"type":42},"2025-10-21",{"date":46,"type":21},"2027-07-05",{"name":48,"class":49},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",6,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100577984","phase-2-timely-integration-of-palliative-care-in-oncology-care-for-patients-referred-for-palliative-radiotherapy-on-bone-metastases-a-randomized-trial-100577984","NCT06805396","Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial","Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial (TIPZO-RT Trial)","TIPZO-RT","Inclusion Criteria:\n\n1. broad informed consent for PRESENT+ (i.e., consent for filling out questionnaires at regular intervals and randomization into future intervention studies), and\n2. having their treating physician in the TIPZO-RT study site (UMC Utrecht, Radboudumc or LUMC).\n\nExclusion Criteria:\n\n1. not able to understand the objective of the study (in Dutch),\n2. cognitive impairment or dementia, and\n3. has been in contact with palliative care consultants of the hospital PCCT before.",{"count":60,"type":21},246,[62],"PHASE2","Rationale: With improvements in systemic tumour-directed treatments for primary tumours, survival rates for patients with bone metastases are improving. However, individual illness trajectories become less predictable and more vulnerable to adverse events from treatments, negatively impacting a patient's quality of life (QoL). Palliative care is aimed at reducing symptoms and improving QoL for patients with incurable diseases through early identification, thorough assessment, and effective management of physical, psychological, social, and spiritual challenges. Early integration of specialist palliative care into oncology care has shown to reduce symptom burden and potentially inappropriate end-of-life care, and to enhance QoL, yet it is often initiated late.\n\nObjective: The primary objective is to evaluate the satisfaction with care and QoL experienced by patients with bone metastases who are offered a consultation with the hospital palliative care consultation team (PCCT) when referred for palliative radiotherapy compared to patients who receive standard of care.\n\nStudy design: A prospective, pragmatic, two-arm multicenter randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT+) cohort that follows the Trials within Cohorts (TwiCs) design.\n\nStudy population: Patients with bone metastases referred for palliative radiotherapy who have their treating physician in one of the participating centers and have not been in contact with the hospital PCCT before.\n\nIntervention: A consultation with the hospital PCCT within two weeks after inclusion in PRESENT+. In the standard of care control group, no consultation with the PCCT will be scheduled. They may have a consultation during follow-up if referring physicians may consider a consultation appropriate, or when patients themselves feel they want a referral.\n\nMain study parameters\u002Fendpoints: Satisfaction with care (affective behavior) four weeks after inclusion in PRESENT+.",[29,65],"Radiotherapy",[67,68,65,69,70,71],"Palliative Care","Bone Metastases","Advanced Cancer","Quality of Life","Quality of Care","2026-05-11",{"date":39,"type":42},{"date":75,"type":42},"2025-06-02",{"date":77,"type":21},"2027-01-31",{"name":79,"class":80},"Roxanne Gal","OTHER",5,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100606164","research-on-the-optimization-of-treatment-for-spinal-metastases-with-radioactive-particle-implantation-using-tps-and-mechanical-dual-simulation-100606164","NCT07171996","Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation","Inclusion Criteria:\n\n* Age ≥18 years.\n\nRadiologically or histologically confirmed bone metastasis with a lesion suitable for percutaneous radioactive seed implantation (e.g., I-125), per multidisciplinary assessment.\n\nIndication for local palliation\u002Fcontrol: moderate-to-severe pain at lesion (e.g., BPI\u002FVAS ≥4) and\u002For imaging evidence of progression or high-risk features warranting local therapy.\n\nMeasurable\u002Fevaluable target lesion on CT\u002FMRI; target location accessible for needle placement per institutional practice.\n\nECOG performance status 0-2.\n\nEstimated life expectancy ≥3 months.\n\nAdequate hemostasis: platelets ≥80×10\\^9\u002FL, INR ≤1.5 (or per protocol), and able to hold\u002Fbridge anticoagulation as clinically indicated.\n\nAdequate organ function to undergo the procedure and anesthesia\u002Fsedation per site standards.\n\nAble to undergo required imaging (CT; MRI if applicable).\n\nWilling and able to provide written informed consent and comply with follow-up.\n\nFor women of childbearing potential and men with partners of childbearing potential: agreement to use effective contraception during and for the protocol-defined period after implantation.\n\nExclusion Criteria:\n\n* Need for urgent surgical decompression or stabilization (e.g., acute\u002Fimpending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time.\n\nUncorrected coagulopathy or ongoing antithrombotic therapy that cannot be safely managed periprocedurally.\n\nActive systemic or local infection at\u002Fnear the planned access route.\n\nDiffuse marrow replacement or extensive cortical destruction where percutaneous implantation is unsafe or unlikely to achieve local control without stabilization, per MDT judgment.\n\nPrior radiation or surgery to the index lesion that, in the investigator's opinion, makes additional seed implantation unsafe or non-beneficial; postoperative bed without a discrete target for seed placement.\n\nKnown hypersensitivity to materials\u002Fagents required for the procedure (e.g., contrast) not amenable to premedication or alternative imaging.\n\nUncontrolled medical conditions posing prohibitive procedural risk (e.g., severe cardiopulmonary disease, uncontrolled hypertension\u002Farrhythmia).\n\nPregnant or breastfeeding.\n\nInability to lie still or contraindications to required imaging\u002Fsedation not correctable.\n\nConcurrent participation in another interventional study that could confound efficacy\u002Fsafety assessment at the treated site.\n\nAny condition that, in the investigator's judgment, would interfere with protocol adherence, safety monitoring, or outcome assessment.","55 Years",{"count":90,"type":21},150,[92],"NA","This prospective, open-label randomized trial evaluates a dual-simulation planning strategy that combines standard brachytherapy TPS with patient-specific biomechanical modeling for radioactive seed implantation in bone metastases. The approach aims to improve dose coverage while accounting for fracture risk, needle path stability, and seed migration. Eligible patients with painful and\u002For progressive bone metastases are randomized to dual-simulation planning versus conventional TPS. All undergo image-guided implantation with post-implant dosimetric verification and standardized follow-up. The primary endpoint is 3-month pain response (BPI\u002FVAS, adjusted for analgesic use). Secondary endpoints include dosimetry (D90, V100, CI, HI), local control\u002Fprogression, seed migration, skeletal-related events and fractures, SINS and functional status, quality of life, procedure-related complications (CTCAE v5.0), and procedure metrics. We hypothesize the dual-simulation strategy will enhance dosimetric quality and reduce biomechanics-related complications, improving pain and function.",[29],[96,97,98],"tps","dynamics","osseous metastasis","2025-09-11",{"date":101,"type":42},"2025-09-15",{"date":103,"type":42},"2025-07-01",{"date":105,"type":21},"2027-06-01",{"name":107,"class":80},"Li Min",1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":108},"100591972","sfrt-and-scart-in-radiotherapy-for-bone-metastases-with-soft-tissue-100591972","NCT06987370","SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue","A Phase II Randomized Controlled Clinical Study on the Efficacy and Safety Evaluation of Radiotherapy Mode Based on SFRT and SCART Technologies for Bone Metastatic Malignant Tumors With Soft Tissue Formation","Inclusion Criteria:\n\n1\\. Sign a written informed consent form before implementing any trial-related procedures; 2. Male or female, aged 18 years or above and 75 years or below; 3. Have a histopathologically confirmed single primary tumor (patients with a pathological diagnosis of small cell carcinoma or undifferentiated carcinoma are excluded); 4. ECOG PS 0-2; 5. Have at least one target lesion: bone metastasis with a soft tissue mass confirmed by CT or MRI. The shortest diameter of the soft tissue is greater than 30mm; 6. The number of metastatic lesions is ≤ 5 and the number of metastatic organs is ≤ 3; 7. The expected survival time is ≥ 3 months; 8. The main organ functions are normal (within 14 days before enrollment), that is, the following criteria are met:\n\n1. The blood routine examination criteria should meet:\n\n   1. Hemoglobin (HB) ≥ 90g\u002FL;\n   2. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL;\n   3. Platelet count (PLT) ≥ 75×10⁹\u002FL;\n2. There is no functional organic disease, and the following criteria should be met:\n\n   1. When there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, alkaline phosphatase (ALP) ≤ 3× ULN; when there is liver metastasis, ALT and AST ≤ 5× ULN, serum total bilirubin ≤ 3× ULN, and alkaline phosphatase (ALP) ≤ 5× ULN;\n   2. Serum creatinine level Cr ≤ 1.5×ULN (if the serum creatinine is elevated, a 24-hour urine collection is required, except for those with a 24-hour creatinine clearance rate \\> 50ml\u002Fmin);\n   3. Urine protein \\\u003C 2+. If the test strip result is ≥ 2+, the 24-hour urine protein must be \\\u003C 2g, or the urine protein-to-creatinine ratio (UPC) must be \\\u003C 2;\n   4. International normalized ratio (INR) and activated partial thromboplastin time (APTT): ≤ 1.5×ULN;\n\nExclusion Criteria:\n\n1. Pathological fracture confirmed by CT or MR.\n2. Prior radiotherapy to the target lesion.\n3. Pregnant or lactating women.\n4. Acute infection or other serious underlying diseases.\n5. Obvious history of neurological and mental diseases, including dementia that may affect the ability to understand and give informed consent.\n6. History or evidence of diseases, treatments or abnormal laboratory test values that may interfere with the test results and prevent the subject from participating in the study throughout the whole process, or other situations that the researcher deems inappropriate for enrollment. The researcher believes that there are other potential risks that make the subject unsuitable for participating in this study.","75 Years",{"count":118,"type":21},90,[92],"This is a randomized, controlled, prospective phase II, two-arm clinical study designed to evaluate the efficacy and safety of using either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Ablative Radiotherapy (SCART) for treating the soft tissue components of malignant bone metastases. The study plans to enroll 90 patients with bone metastases accompanied by soft tissue formation, who will be randomized in a 2:1 ratio to the SFRT\u002FSCART group or the conventional radiotherapy (CRT) group.The primary endpoint is the objective response rate (ORR). Tumor response to treatment will be assessed every 12 weeks (±7 days) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary endpoints include pain relief rate, progression-free survival (PFS), and safety. In addition, adverse events (AEs) will be monitored throughout the study.",[29],[123,124,125,126],"bone metastases","bone metastases with soft tissue","SFRT","SCART","2025-07-04",{"date":129,"type":42},"2025-07-08",{"date":131,"type":42},"2025-06-01",{"date":133,"type":21},"2027-11-30",{"name":135,"class":80},"Shandong Cancer Hospital and Institute"]