[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yong He\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100656881","phase-2-diagnostic-performance-of-acp3-targeted-pet-imaging-in-patients-with-primary-and-recurrent-prostate-cancer-an-open-label-single-arm-single-center-study-100656881",false,"NCT07830212","Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study","A Study to Evaluate the Diagnostic Performance of ACP3-Targeted PET Imaging in Patients With Primary and Recurrent Prostate Cancer: An Open-Label, Single-Arm, Single-Center Study","Inclusion Criteria:\n\n* Voluntary participation and signed written informed consent before any study-specific procedures;\n* Male, aged 18 to 90 years;\n* Clinically suspected high-risk, histologically confirmed, or suspected recurrent prostate cancer after treatment;\n* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study-related procedures;\n* Expected survival time greater than 6 months;\n* Participants' partners agree to use reliable contraceptive measures (such as abstinence, sterilization surgery, oral contraceptives, injectable medroxyprogesterone acetate, or subdermal implants) during the study and for at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Known or suspected allergy to \\[68Ga\\]Ga-OncoACP3 injection or any of its excipients;\n* Any severe unstable disease (e.g., severe cardiac, pulmonary, hepatic, or renal insufficiency) that, in the investigator's judgment, makes the participant unsuitable for the study;\n* Inability to complete PET\u002FCT examination, including inability to lie flat, claustrophobia, or radiophobia;\n* Poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study;\n* Prior use of a radiopharmaceutical within less than 10 physical half-lives before study drug administration;\n* Currently participating in or planning to participate in any drug or device clinical trial during the study period.","MALE","18 Years","90 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study aims to evaluate the diagnostic performance of \\[68Ga\\]Ga-OncoACP3 PET imaging, which targets prostate acid phosphatase (ACP3), in men with clinically suspected or confirmed high-risk prostate cancer, or suspected recurrence after treatment. The study will assess the ability of this imaging to detect lesions and its diagnostic performance, including sensitivity, specificity, and accuracy. Histopathology and\u002For clinical follow-up of at least 6 months will be used as the reference standard. Participants will receive a single intravenous injection of \\[68Ga\\]Ga-OncoACP3 and undergo a PET\u002FCT scan about 1 hour later. For participants who have already undergone clinically routine PSMA PET imaging, a comparison between the two imaging modalities will be performed. The study will enroll 50 men aged 18 to 90 years. Additionally, the study will explore the correlation between semi-quantitative parameters derived from \\[68Ga\\]Ga-OncoACP3 PET imaging and pathological markers (ACP3 expression assessed by immunohistochemistry in tumor tissue), and will evaluate the impact of \\[68Ga\\]Ga-OncoACP3 PET imaging on clinical treatment decisions.",[27,28],"Prostatic Neoplasms","Prostate Cancer",[30,31,32,33],"Prostate acid phosphatase","[68Ga]Ga-OncoACP3 PET\u002FCT","Diagnostic performance","Prostate cancer","NOT_YET_RECRUITING","2026-09-21",{"date":37,"type":38},"2026-09-23","ACTUAL",{"date":40,"type":21},"2026-10",{"date":42,"type":21},"2028-06",{"name":44,"class":45},"Yong He","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":70,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":46},"100655721","phase-1-safety-and-diagnostic-performance-of-111in-tjd-31-spect-imaging-in-patients-with-solid-tumors-100655721","NCT07815951","Safety and Diagnostic Performance of 111In-TJD-31 SPECT Imaging in Patients With Solid Tumors","A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety, Biodistribution, Dosimetry, and Preliminary Diagnostic Performance of a Novel SPECT Tracer 111In-TJD-31 in Patients With Solid Tumors","Inclusion Criteria:\n\n* For Patients with Solid Tumors:\n\n  1. Voluntary signed written informed consent before any study-specific procedures;\n  2. Clinically highly suspected or histologically (or cytologically) confirmed malignant solid tumors with measurable lesions (target lesions), including treatment-naïve and relapsed patients;\n  3. Age ≥18 and ≤75 years, male or female;\n  4. ECOG performance status 0 or 1;\n  5. Life expectancy ≥6 months;\n  6. Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration.\n\nFor Healthy Volunteers:\n\n1. Chinese healthy volunteers, male or female;\n2. Age 18 to 55 years (inclusive);\n3. Body weight: females 45-80 kg (inclusive), males 50-80 kg (inclusive);\n4. Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration;\n5. Ability to communicate well with the investigator, understand and comply with all study requirements, and voluntarily sign informed consent before any study-related procedures.\n\nExclusion Criteria:\n\n* For Patients with Solid Tumors:\n\n  1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration;\n  2. Known or suspected allergy to the study drug or any of its components;\n  3. Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer;\n  4. Use of any radiotherapeutic agent within 90 days prior to study drug administration, or use of any radionuclide diagnostic agent within 3 days prior to study drug administration;\n  5. Significant hepatic or renal dysfunction: serum total bilirubin \\>1.5 × upper limit of normal (ULN), or AST and\u002For ALT \\>2.5 × ULN, or serum creatinine \\>1.5 × ULN;\n  6. Active infection at screening;\n  7. Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging;\n  8. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.\n\nFor Healthy Volunteers:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration;\n2. Known or suspected allergy to the study drug or any of its components;\n3. Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer;\n4. Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening;\n5. History of any clinically significant disease (including but not limited to cardiac, hepatic, renal, digestive, biliary, endocrine, cardiovascular, neurological, psychiatric, respiratory, immunological, hematological, hematopoietic, or urinary system disease) within 4 weeks prior to screening, as judged by the investigator;\n6. Blood pressure \\>150\u002F100 mmHg or \\\u003C90\u002F50 mmHg at screening;\n7. Use of any prescription or over-the-counter medication (including herbal medicines, dietary supplements, and vitamins, except for routine continuous vitamin use) within 2 weeks prior to study drug administration, unless judged by the investigator as not affecting the study results;\n8. Blood donation or blood loss ≥500 mL within 12 weeks prior to study drug administration;\n9. History of any malignant tumor;\n10. Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging;\n11. Any other condition that, in the investigator's opinion, makes the volunteer unsuitable for the study.",true,"ALL","75 Years",{"count":58,"type":21},8,[60],"PHASE1","This study aims to evaluate the performance of a novel SPECT imaging agent, 111In-TJD-31, which targets placental alkaline phosphatase (ALPP). ALPP is a protein found on the surface of many malignant solid tumor cells but rarely present in healthy adult tissues. The purpose of this study is to assess the ability of 111In-TJD-31 to detect tumor lesions in patients with malignant solid tumors, as well as to evaluate its safety, biodistribution, pharmacokinetics, and radiation dosimetry.\n\nThe study will enroll 8 participants: 2 healthy volunteers and 6 patients with confirmed malignant solid tumors. Healthy volunteers will provide blood samples at multiple time points after a single intravenous injection of 111In-TJD-31 to help measure how the agent moves through the body. Patients with malignant solid tumors will receive a single intravenous injection of 111In-TJD-31 and undergo SPECT\u002FCT imaging at several time points post-injection. Participants will be followed for safety assessments through Day 7 after injection.\n\nThis is an open-label, exploratory study conducted at Zhongnan Hospital of Wuhan University, with support from Tuo Jiding (Jiaxing) Pharmaceutical Technology Co., Ltd.",[63,64,65,66,67,68,69],"Solid Tumors","Carcinoma","Ovarian Neoplasms","Endometrial Neoplasms Malignant","Testicular Neoplasms","Lung Neoplasms","Gastrointestinal Neoplasms",[71,72,73,74,75,76],"Placental Alkaline Phosphatase","SPECT Imaging","111In-TJD-31","Solid Tumor Diagnosis","radiation dosimetry","pharmacokinetics","2026-09-06",{"date":79,"type":38},"2026-09-11",{"date":81,"type":21},"2026-09",{"date":83,"type":21},"2027-12-31",{"name":44,"class":45},""]