[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547226":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":24,"responsibleParty":45,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":18,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":18,"overallStatus":27,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Recombinant human thyroid stimulating hormone group","EXPERIMENTAL","Recombinant human thyroid stimulating hormone injection: 0.9mg\u002F1.0mL\u002Fpiece; intramuscular injection; once a day for two consecutive days",[13],"Drug: Recombinant Human Thyroid Stimulating Hormone",{"label":15,"type":16,"description":17,"interventionNames":18},"Withdraw group","NO_INTERVENTION","Thyroid hormone withdraw for 4-6 weeks",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DRUG","Recombinant Human Thyroid Stimulating Hormone",[9],[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Nanjing First Hospital","RECRUITING","Nanjing","Jiangsu","210006","China","CN",{"type":34,"coordinates":35},"Point",[36,37],118.77778,32.06167,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":18,"email":44},"Feng Wang, Ph.D.","CONTACT","86-025-52271455","fengwangcn@hotmail.com",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Feng Wang","Director of nuclear medicine department","100547226","recombinant-human-thyroid-stimulating-hormone-for-radioiodine-131i-treatment-100547226",false,"NCT06405217","Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment","Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced\u002FMetastatic Differentiated Thyroid Cancer","Inclusion Criteria:\n\n* Age: 18\\~75 years old (including 18 and 75 years old);\n* ECOG: 0-2 points;\n* Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.\n* Hemoglobin ≥80g\u002FL, neutrophil ≥1.5×109\u002FL, platelet count ≥80×109\u002FL, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml\u002Fmin, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g\u002FL;\n* Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);\n* Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up.\n\nExclusion Criteria:\n\n* Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association classification); 3) Poorly controlled diabetes (fasting blood sugar \\>10mmol\u002FL); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU\u002FmL; hepatitis C: positive hepatitis C virus RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.\n* Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;\n* Unable to quit or with a history of psychiatric medication abuse;\n* Allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131I) or its excipients;\n* Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;\n* Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening;\n* Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;\n* Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study;\n* Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.","ALL","18 Years","75 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"NA","Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer .\n\nExperimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg\u002F1.0mL\u002Fpiece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks.\n\nThe two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (\\>30mU\u002FL). The efficacy and adverse reactions were observed.",[67,68,69],"DTC - Differentiated Thyroid Cancer","Thyroid Stimulating; Hormone, C","Radiotherapy; Complications","2024-05-03",{"date":72,"type":73},"2024-05-08","ACTUAL",{"date":75,"type":73},"2024-04-20",{"date":77,"type":61},"2026-12-31",{"name":5,"class":6},1]