[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sinotau Pharmaceutical Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,73,99,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100626707","phase-3-comparison-of-diagnostic-accuracy-between-xtr004-pet-mpi-and-the-composite-index-of-quantitative-coronary-angiography-qca-and-fractional-flow-reserve-ffr-100626707",false,"NCT07439133","Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)","Evaluation of the Efficacy and Safety of XTR004 Injection in Detecting Blood Flow Restrictive Stenosis in Patients With Suspected or Known Stable Coronary Artery Disease: A Multicenter, Open-Label, Phase III Clinical Trial","Inclusion Criteria:\n\n* Participants aged 18 to 80 years, male or female.\n* Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes, obesity (BMI ≥28), a history of alcohol abuse, a smoking history, a family history of coronary heart disease, postmenopausal status, or age 60 years or older.\n* Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III\u002FIV angina pectoris), uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and\u002For diastolic ≥110 mmHg despite long-term regular antihypertensive medication), hypotension (resting systolic blood pressure \\\u003C90 mmHg), acute myocardial infarction, second or third-degree atrioventricular block, sinoatrial node disease, NYHA Class III\u002FIV heart failure, dilated or hypertrophic cardiomyopathy, pericarditis, valvular heart disease, aortic dissection, uncontrolled severe arrhythmias, congenital heart disease, those who have undergone coronary artery bypass grafting or interventional procedures within three months, and those determined unsuitable for participation in this study by investigators;\n* Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc.) who are determined unsuitable for participation by the investigator;\n* Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active epilepsy, CNS infections, CNS diseases accompanied by mental disorders or motor impairments) who are determined unsuitable for participation by the investigator;\n* Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.) who are determined unsuitable for participation by the investigator;\n* Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who are determined unsuitable for participation by the investigator;\n* Participants with severe kidney impairment (including but not limited to glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous nephropathy, hydronephrosis, renal cystopathy, etc.) who are determined unsuitable for participation by the investigator;\n* Participants with fever or active infectious diseases who are determined unsuitable for participation by the investigator;\n* Participants with known alcohol allergy who are determined unsuitable for participation by the investigator;\n* participants with known adenosine allergy who are determined unsuitable for participation by the investigator;\n* Participants with known iodine contrast agent allergy who are determined unsuitable for participation by the investigator;\n* Within the past 10 years, significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv\u002Fyear) or exposure to radioactive substances or ionizing radiation for therapeutic\u002Fresearch purposes;\n* Male or women of childbearing age not using effective contraception during study participation and within 6 months post-study (effective contraception refers to sterilization, intrauterine device, condoms, abstinence, or surgical blockage of vas deferens\u002Ffallopian tubes);\n* Female participants in pregnancy or lactation\n* Individuals with claustrophobia, bipolar disorder, mental disorders, or poor compliance;\n* Participation in other investigational drug trials within 30 days prior to enrollment or planned during study;\n* Any other circumstances determined unsuitable by investigators.","ALL","18 Years","80 Years",{"count":20,"type":21},395,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.",[27],"Coronary Artery Disease(CAD)","RECRUITING","2026-02-27",{"date":31,"type":32},"2026-03-03","ACTUAL",{"date":34,"type":32},"2025-11-14",{"date":36,"type":21},"2027-10",{"name":38,"class":39},"Sinotau Pharmaceutical Group","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100627058","phase-2-pet-myocardial-fatty-acid-metabolic-imaging-with-xtr003-injection-and-18f-fdg-to-assess-myocardial-viability-in-ischemic-cardiomyopathy-100627058","NCT07443696","PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy","A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy","STB-XTR-003","Inclusion Criteria:\n\n1. Aged 18 to 85 years, regardless of gender.\n2. Diagnosed with ischemic cardiomyopathy (ICM).\n3. significant coronary artery disease (CAD).\n4. Left ventricular systolic dysfunction, with LVEF ranging from \\>20% to ≤40%\n5. Assessed by a team of cardiac surgeons\u002Foperators as suitable for complete revascularization.\n6. Capable of effective communication with the investigators, able to understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent after being fully informed.\n\nExclusion Criteria:\n\n1. Decompensated heart failure within 48 hours prior to enrollment.\n2. Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.\n3. Left ventricular aneurysm.\n4. Judged by the investigator as unable to complete PET examination.\n5. Severe renal insufficiency.\n6. Severe hepatic insufficiency.\n7. Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.\n8. Pregnant or lactating women.\n9. Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.\n10. Subjects with mental disorders or poor compliance.\n11. Significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv per year) or exposure to radioactive substances\u002Fionizing radiation for therapeutic or research purposes within the past 10 years.\n12. Other circumstances deemed by the investigator as unsuitable for trial participation.","85 Years",{"count":50,"type":21},40,[52],"PHASE2","This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003\u002F18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality.\n\nAll study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).",[55,56],"Ischemic Cardiomyopathy","Heart Failure",[58,59,60,61,62,63],"18F-FDG","XTR003","position emission tomography","myocardial metabolic imaging","myocardial viability","ischemic cardiomyopathy","2026-02-26",{"date":66,"type":32},"2026-03-02",{"date":68,"type":32},"2025-12-18",{"date":70,"type":21},"2026-12",{"name":38,"class":39},3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100604462","phase-1-a-clinical-trial-evaluating-the-safety-and-tolerability-biodistribution-and-radiation-dosimetry-and-pharmacokinetics-of-flotufolastat-f-18-injection-in-healthy-chinese-adults-100604462","NCT07149831","A Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults","An Open-label, Single-center, Single-arm Phase I Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults","Inclusion Criteria:\n\n1. Have the ability to understand the content of study and voluntarily sign the informed consent form.\n2. Healthy male or female, aged 18-60 (included).\n3. Body mass index (BMI) between 19 and 26 kg\u002Fm² (included).\n4. Vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant.\n5. Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant.\n6. Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up.\n7. Female subject shouldcontracept effectively during the study period and 6 months after the study completed (effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills\u002Fagents, abstinence, or partner vasectomy). Male subject should agree to use contraception during the study period and 6 months after the study completed.\n\nExclusion Criteria:\n\n1. Claustrophobia or inability to tolerate imaging examinations for any other reason.\n2. Have a history of epilepsy or seizures, excluding childhood febrile seizures.\n3. With chronic diseases, including but not limited to:\n\n   1. cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof.\n   2. history of psychiatric disorders or currently significant psychiatric conditions\n4. Have a history of asthma or allergies.\n5. Have a history of malignant tumors.\n6. Present any condition that may interfere with the absorption or metabolism of the investigational drug, or that may affect study results, as determined by the investigator to be clinically significant.\n7. Underwent any surgical procedure within 3 months before administration or planned surgery during the study period.\n8. Accomplished the blood donation or significant blood loss (\\>400 mL) within 3 months before administration or during the screening period.\n9. Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling).\n10. Known allergy to the active ingredient or any excipients of the investigational product.\n11. Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration.\n12. Participated any other new drug's clinical trial within 4 weeks prior to the administration or within 5 half-lives of the investigating drug (whichever is longer).\n13. Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer).\n14. Pregnant or breastfeeding women.\n15. Abnormal serological results (hepatitis B surface antigen, syphilis treponemal antibody, human immunodeficiency virus antibody, hepatitis C antibody) diagnosed clinically significant by the investigator.\n16. QTc intervalis longer than 450 milliseconds during the screening period.\n17. Major occupational exposure to ionizing radiation in the past 10 years (e.g., more than 50 mSv\u002Fyear) or exposure to radioactive materials or ionizing radiation for therapeutic or research purposes.\n18. Any reason determined by the investigator that could not complet the study.",true,"60 Years",{"count":83,"type":21},6,[85],"PHASE1","Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of Flotufolastat F-18 Injection in 6 healthy elderly Chinese volunteers.",[88],"Prostate Cancer",[88],"2025-08-29",{"date":92,"type":32},"2025-09-02",{"date":94,"type":32},"2025-06-07",{"date":96,"type":21},"2025-12-31",{"name":38,"class":39},1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":106,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":98},"100601805","diagnostic-efficacy-and-safety-of-flotufolastat-f-18-injection-in-subjects-with-biochemical-recurrence-of-prostate-cancer-100601805","NCT07115277","Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer","A Single-arm, Multicenter, Phase III Clinical Trial , Evaluate the Diagnostic Performance and Safety of Flotufolastat F-18 Injection PET Imaging in Prostate Cancer Subjects With Biochemical Recurrence Following Prior Treatment","Inclusion Criteria:\n\n1\\. Fully understand the study and voluntarily sign the informed consent form. 2. Male, aged ≥18 years. 3. Has previously received one or more of the following treatments:\n\n1. Radical prostatectomy (RP);\n2. RP with adjuvant radiotherapy (RT);\n3. RP with adjuvant androgen deprivation therapy (ADT);\n4. Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound \\[HIFU\\]).\n\n   4\\. Clinically suspected BCR, serum PSA levels should meet at least one of the followings:\n   1. After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng\u002FmL, and subsequent confirmation that PSA ≥ 0.2 ng\u002FmL.\n   2. After RT as primary treatment: PSA increased at least 2 ng\u002FmL compaire to the nadir.\n   3. After focal gland therapy as primary treatment: PSA increased at least 2 ng\u002FmL compaire to the nadir.\n\n   5\\. If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation.\n\n   6\\. Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.\n\n   Exclusion Criteria:\n   1. Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.\n   2. Participation in an interventional clinical trial involving a new drug or treatment within 30 days or 5 biological half-lives of the drug prior to XTR020 PET imaging (whichever is longer).\n   3. Known allergy to the active ingredient or any excipient of XTR020.\n   4. Claustrophobia or inability to tolerate imaging examinations for any other reason.\n   5. Poor compliance or deemed unsuitable for participation in this study by the investigator.\n   6. Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.","MALE",{"count":108,"type":21},121,[110],"NA","The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is:\n\n• What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard?\n\nParticipants will:\n\n* Receive Flotufolastat F-18 injection\n* Undergo PET\u002FCT scanning",[88],"2025-08-04",{"date":115,"type":32},"2025-08-11",{"date":117,"type":32},"2025-03-14",{"date":119,"type":21},"2026-12-31",{"name":38,"class":39},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":80,"sex":16,"minAge":128,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":98},"100601803","phase-3-analysis-of-18f-xtr006-pet-imaging-in-cognitively-normal-subjects-and-patients-with-mci-and-ad-100601803","NCT07115238","Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD","A Phase 3, Multicenter Study to Evaluate the Efficacy and Safety of PET Visual Assessment Using XTR006 Injection for Detection of Brain Neurofibrillary Tangles (NFTs) in Elderly Subjects","Inclusion Criteria:\n\nInclusion Criteria for All Subjects:\n\n1. Male or female subjects aged ≥50 years.\n2. Able to tolerate both PET and MRI examinations.\n3. Must use contraceptive measures during the study period and for 6 months after study completion.\n4. Written informed consent must be obtained before any assessment is performed.\n\nInclusion Criteria for Cognitively Normal Subjects:\n\n1)CDR (Clinical Dementia Rating) score of 0. 2）MMSE (Mini-Mental State Examination) score ≥28. 3）Negative visual reading result on brain Aβ-PET imaging.\n\nInclusion Criteria for Subjects with MCI:\n\n1. Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards\n2. Positive visual reading result on brain Aβ-PET imaging\n\nInclusion Criteria for Subjects with AD:\n\n1. Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards:\n2. Positive visual reading result on brain Aβ-PET imaging.\n\nExclusion Criteria:\n\n1. Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia.\n2. Current significant psychiatric illness with symptoms that prevent completion of imaging procedures.\n3. MRI-confirmed structural brain abnormalities, such as large stroke or intracranial mass lesions.\n4. Claustrophobia.\n5. History of alcohol abuse or drug abuse\u002Fdependence.\n6. Allergy to the study drug or any of its components.\n7. Women who are currently breastfeeding.","50 Years",{"count":130,"type":21},354,[24],"The goal of this clinical trial is to evaluate the efficacy and safety of XTR006 injection PET visual reading in detecting brain neurofibrillary tangles (NFTs) in elderly subjects with Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), and cognitively normal individuals. The main question it aims to answer is:\n\n• What is the sensitivity and specificity of XTR006 PET visual reading results compared to the truth standard across MCI, AD, and cognitively normal subjects?\n\nParticipants will:\n\n* Receive XTR006 injection\n* Undergo PET\u002FCT scanning",[134,135],"Alzheimer Disease","Neurofibrillary Tangle",{"date":115,"type":32},{"date":138,"type":32},"2024-11-20",{"date":140,"type":21},"2026-06-30",{"name":38,"class":39},""]