[{"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:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,65,97,121,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100546707","phase-2-a-clinical-study-of-lutetium177lu-oxodotreotide-injection-in-patients-with-advanced-neuroendocrine-neoplasms-100546707",false,"NCT06398444","A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms","A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms","Inclusion Criteria:\n\n1. Subjects who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).\n2. Age ≥12 years; subjects aged 12-17 years must have a body weight ≥40kg. Age eligibility must be met at the time of signing the ICF.\n3. Histologically confirmed, unresectable locally advanced or metastatic neuroendocrine neoplasms (NENs) \\[excluding well-differentiated (G1 and G2) gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) and neuroendocrine carcinomas (NECs)\\]. The target population mainly includes:\n\n(1)Grade 3 (G3) GEP-NET with Ki-67 index ≤ 55% (2)Other non-gastroenteropancreatic originated NEN, including pulmonary\u002Fthymic NEN, primary NEN of other sites, and NEN of unknown primary origin (3)Pheochromocytoma and paraganglioma (PPGL) Note: Histopathological specimens collected within 3 years prior to the first study drug administration are acceptable, provided that investigators confirm they can represent the pathological status at enrollment; otherwise, fresh specimens shall be collected.\n\n4\\. Patients who have failed prior optimal available treatment, are intolerant to optimal available treatment, or have no access to optimal available treatment, with no restriction on the number of prior treatment lines.\n\nNote: Optimal available treatment is determined by investigators based on individual subject conditions, including chemotherapy, targeted therapy, biologic therapy, etc.\n\n5.Have documented disease progression within 1 year prior to the first study drug administration, and have not received any other systemic anti-tumor therapy after disease progression.\n\n6.Have at least one measurable lesion at baseline per RECIST 1.1 criteria. 7. All baseline target lesions (per RECIST 1.1) must be confirmed as somatostatin receptor-positive via ⁶⁸Ga-Dotatate PET\u002FCT.\n\nNotes:\n\n1. ⁶⁸Ga-Dotatate PET\u002FCT images obtained within 24 weeks before the first drug administration are acceptable if investigators verify they can reflect the somatostatin receptor status at enrollment;\n2. Somatostatin receptor positivity is defined as lesion uptake higher than normal liver uptake;\n3. Subjects with any target lesion confirmed somatostatin receptor-negative by ⁶⁸Ga-Dotatate PET\u002FCT shall be excluded.\n\n8\\. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at baseline.\n\n9\\. Subjects of childbearing potential must voluntarily use effective contraceptive methods throughout the treatment period and for 4 months (male) or 7 months (female) after the last dose of investigational product, such as condoms, oral\u002Finjectable contraceptives, intrauterine devices, etc.\n\nExclusion Criteria\n\n1. Serum creatinine \\> 150 μmol\u002FL (1.7 mg\u002FdL) or creatinine clearance rate \\\u003C 50 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n2. Hemoglobin \\\u003C 100 g\u002FL, white blood cell count \\\u003C 2.0×10⁹\u002FL, or platelet count \\\u003C 100×10⁹\u002FL.\n3. Total serum bilirubin \\> 3 times the upper limit of normal (ULN).\n4. Serum albumin \\\u003C 30 g\u002FL.\n5. Alanine transaminase (ALT) or aspartate transaminase (AST) \\> 2.5×ULN.\n6. International Normalized Ratio (INR) \\> 1.5 or activated partial thromboplastin time (APTT) \\> 1.5×ULN.\n7. Positive human immunodeficiency virus (HIV) antibody.\n8. Positive hepatitis B surface antigen (HBsAg) combined with positive HBV-DNA (≥1×10⁴ copies\u002FmL or confirmed positive per local study center criteria); or positive hepatitis C virus (HCV) antibody combined with positive HCV-RNA (≥1×10³ copies\u002FmL).\n9. Pregnant or breastfeeding females.\n10. Prior history of peptide receptor radionuclide therapy (PRRT).\n11. Subjects receiving short-acting octreotide who cannot discontinue it within 24 hours before and after administration of Lutetium-177 Oxotreotide Injection; or subjects receiving octreotide acetate microspheres who cannot stop the treatment within 6 weeks prior to the first dose of Lutetium-177 Oxotreotide Injection.\n\n    Note: Further evaluation is required for subjects receiving other somatostatin analog (SSA) treatments.\n12. Received systemic anti-tumor therapies including targeted therapy, immunotherapy, anti-tumor traditional Chinese medicine therapy or chemotherapy within 4 weeks before the first study drug administration.\n13. Enrolled in other clinical trials and received investigational drugs within 4 weeks prior to the first dose.\n14. Received local anti-tumor treatments such as surgery (excluding biopsy), radical radiotherapy, hepatic arterial chemoembolization, cryoablation or radiofrequency ablation for liver metastases within 4 weeks before the first dose.\n15. Received palliative radiotherapy for bone metastases within 2 weeks prior to the first dose.\n16. Toxicities from previous anti-tumor therapies have not recovered to Grade 1 or lower (alopecia excluded).\n17. Confirmed brain metastases (excluding those stabilized for at least 24 weeks before the first administration).\n18. Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) \\\u003C 50%.\n19. Uncontrolled diabetes mellitus, including baseline fasting blood glucose \\> 2×ULN.\n20. Presence of active infections requiring intravenous antibacterial drugs or inpatient intervention.\n21. History of other confirmed malignant tumors (excluding those with complete treatment and expected no recurrence within 5 years).\n22. Known hypersensitivity to any ingredients or excipients of Lutetium-177 Oxotreotide Injection and octreotide acetate microspheres.\n23. Contraindications to contrast-enhanced CT and MRI contrast agents due to allergic reactions or renal insufficiency.\n24. Any uncontrolled diseases, mental disorders or surgical conditions that may affect study completion (including poor treatment compliance) or make subjects ineligible for the investigational product.\n25. Based on the patient's disease characteristics, the investigator judges that alternative treatments such as chemotherapy and targeted therapy are more suitable for the patient than the study treatment, meaning the investigational product is not the optimal clinical treatment option.","ALL","12 Years",{"count":19,"type":20},85,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium \\[177Lu\\] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1\u002FG2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) and Neuroendocrine Carcinoma（NEC）.",[27],"Advanced Neuroendocrine Neoplasm","RECRUITING","2026-07-15",{"date":31,"type":32},"2026-07-17","ACTUAL",{"date":34,"type":32},"2024-06-11",{"date":36,"type":20},"2029-06-01",{"name":38,"class":39},"Sinotau Pharmaceutical Group","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"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","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.","18 Years","80 Years",{"count":51,"type":20},395,[24],"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.",[55],"Coronary Artery Disease(CAD)","2026-02-27",{"date":58,"type":32},"2026-03-03",{"date":60,"type":32},"2025-11-14",{"date":62,"type":20},"2027-10",{"name":38,"class":39},5,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"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":75,"type":20},40,[23],"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).",[79,80],"Ischemic Cardiomyopathy","Heart Failure",[82,83,84,85,86,87],"18F-FDG","XTR003","position emission tomography","myocardial metabolic imaging","myocardial viability","ischemic cardiomyopathy","2026-02-26",{"date":90,"type":32},"2026-03-02",{"date":92,"type":32},"2025-12-18",{"date":94,"type":20},"2026-12",{"name":38,"class":39},3,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":16,"minAge":48,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":40},"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":5,"type":20},[108],"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.",[111],"Prostate Cancer",[111],"2025-08-29",{"date":115,"type":32},"2025-09-02",{"date":117,"type":32},"2025-06-07",{"date":119,"type":20},"2025-12-31",{"name":38,"class":39},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":128,"minAge":48,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":40},"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":130,"type":20},121,[132],"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",[111],"2025-08-04",{"date":137,"type":32},"2025-08-11",{"date":139,"type":32},"2025-03-14",{"date":141,"type":20},"2026-12-31",{"name":38,"class":39},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":104,"sex":16,"minAge":150,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":40},"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":152,"type":20},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",[156,157],"Alzheimer Disease","Neurofibrillary Tangle",{"date":137,"type":32},{"date":160,"type":32},"2024-11-20",{"date":162,"type":20},"2026-06-30",{"name":38,"class":39},""]