[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054224":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":43,"locations":52,"responsibleParty":72,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":30,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":96,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"177Lu-DOTA-EB-TATE","EXPERIMENTAL","Open-Label Study of the Safety, Dosimetry and Efficacy of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients with Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer",[13],"Drug: 177Lu-DOTA-EB-TATE",{"label":15,"type":16,"description":17,"interventionNames":18},"68Ga-DOTA-TATE PET Scan","OTHER","The radiopharmaceutical 68Ga-DOTATATE is acquired by the NIH PET department in the Clinical Center. The radiopharmaceutical is synthetized on the day of the study and a premade dose of 5 mCi is administered.",[19],"Diagnostic Test: 68Ga-DOTA-TATE PET Scan",{"label":21,"type":16,"description":22,"interventionNames":23},"Amino acid infusions","Concomitant administration of an amino acid infusion with the study drug 177Lu-DOTA-EB-TATE is for renal protection.",[24,13],"Other: Amino acid infusions",[26,31,34],{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","68Ga-DOTATATE is administered via intravenous injection of 5 1 mCi in a volume of 3 - 5 ml containing up to 50 micrograms \\[68Ga\\] DOTATATE.",[15],null,{"type":16,"name":21,"description":32,"armGroupLabels":33,"otherNames":30},"Appropriate amino acid solutions infused for this purpose should have a total lysine and arginine content between 18g and 25g and have an osmolality of \\\u003C= 1050 mOsmol. Concomitant administration of an amino acid infusion with the study drug 177Lu-DOTA-EB-TATE is for renal protection.",[21],{"type":35,"name":9,"description":36,"armGroupLabels":37,"otherNames":30},"DRUG","Each single-dose vial contains sodium acetate (24.6 mg\u002FmL), gentisic acid (3.7 mg\u002FmL), L-ascorbate (0.445 mg\u002FmL), DTPA (0.051 mg\u002FmL). 177Lu-DOTA-EB-TATE, is a long-acting radiopharmaceutical for PRRT. It consists of a somatostatin analog peptide (TATE) conjugated with a truncated Evans blue (EB) molecule and the metal chelator 1,4,7,10-tetraazacyclodecane-1,4,7,10-tetraacetic acid (DOTA) with the radioisotope 177Lu stably complexed.",[9,21],[39],{"name":40,"affiliation":41,"role":42},"Joanna Klubo-Gwiezdzinska, M.D.","National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Padmasree Veeraraghavan, R.N.","CONTACT","(301) 451-7710","padmasree.veeraraghavan@nih.gov",{"name":40,"role":46,"phone":50,"phoneExt":30,"email":51},"(301) 496-5052","joanna.klubo-gwiezdzinska@nih.gov",[53],{"facility":54,"status":30,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-77.10026,38.98067,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":69,"phoneExt":70,"email":71},"NIH Clinical Center Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100054224","phase-1-177lu-dota-eb-tate-in-adult-patients-with-metastatic-radioactive-iodine-non-responsive-oncocytic-hurthle-cell-thyroid-cancer-100054224",false,"NCT06991738","177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer","Phase 1\u002F2, Open-Label Study of the Safety, Dosimetry and Efficacy of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 18 years or older.\n* Metastatic RAI-non-responsive and\u002For RAI-non-avid oncocytic (Hurthle cell) thyroid cancer.\n* Progressive disease by RECIST 1.1 criteria, with or without symptoms within the last 12 months. This applies to patients with non-measurable disease by RECIST 1.1 criteria, who will be eligible if they have evidence of progression as defined by the development of new lesions within the last 12 months.\n* High expression of SSTR2 in at least one metastatic lesion as documented by 68Ga-DOTATATE PET\u002FCT with SUVmax \\> SUVmax of the liver consistent with Krenning score of \\>2 or SUVmax \\>= 13 based on scan performed within 12 weeks of anticipated enrollment.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant or breastfeeding.\n* NET\u002FPET score of 5 by imaging with 68Ga-DOTATATE PET\u002FCT and 18FDG-PET\u002FCT and defined more than 2 lesions that are SSTR2 negative but 18FDG positive and\u002For more than 2 lesions that have significantly higher uptake of 18FDG than 68Ga-DOTATATE\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical record.\n* Patient weight \\> 500 lbs. (due to the PET scanner table limit).\n* Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.\n* Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives (whichever is longer), before the first administration of study drug.\n* Previous surgery \\\u003C 6 weeks prior to the start of participation in this study, or participant has not fully recovered from major surgery, or has suffered significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.\n* Life expectancy \\\u003C 6 months as assessed by the treating physician.\n* Karnofsky performance status scale \\\u003C 70%.\n* Inability or unwillingness to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men). The adequate contraception consists of intrauterine device, contraceptive implant, hormonal contraception or a double-barrier method. If the patient is status post tubal ligation, status post hysterectomy and\u002For oophorectomy, or their male partners are status post vasectomy, no additional method of contraception is required.\n* Deteriorated renal function, as indicated by a creatinine clearance \\\u003C60 mL\u002Fmin calculated by the Cockcroft-Gault Equation. The calculated creatinine clearance can be confirmed by measured creatinine clearance.\n* Having only one functional kidney, due to potential nephrotoxicity.\n* Patients who have had any prior EBRT dose to either kidney.\n* Deteriorated bone marrow function, as indicated by:\n\n  * Hemoglobin (Hb) \\\u003C 8.0 g\u002FdL\n  * White blood cell (WBC) \\\u003C 2 x10\\^3\u002FuL\n  * Absolute neutrophil count (ANC) \\\u003C 1.0 x 10\\^3\u002FL\n  * Platelets \\\u003C100 x 10\\^3\u002FmicroL\n* Deteriorated liver function, as indicated by one or more of the following:\n\n  * International normalized ratio (INR) \\> 2.0 for patients that are not on Coumadin\n  * Prothrombin time (PTT) \\> 2 x ULN\n  * Total bilirubin \\> 3 mg\u002FdL\n  * Serum albumin \\\u003C 3.0 g\u002FdL unless prothrombin time is within the normal range\n  * Alanine aminotransferase (ALT) \\> 3 x ULN\n  * Aspartate aminotransferase (AST) \\> 3 x ULN.\n* Previous local therapy \\\u003C4 weeks prior to study entry.\n* Extended QTc interval above 480 ms confirmed by 2 ECGs. If the first ECG conducted at the screening visit shows extended QTc interval, potential participants will be asked to repeat an ECG within 30 days to confirm. The second ECG can be conducted at NIH CC or at their outside provider, at their potential expense.\n* Toxicities from prior therapies that have not resolved to grade 1 or grade 0 excluding dry mouth syndrome from previous RAI and grade 2 anemia\u002Fleukopenia as Hgb\\>=8 g\u002Fdl, WBC \\>=2 x10\\^3\u002FuL and ANC \\>= 1.0 x 10\\^3 are acceptable for enrollment.\n* Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. Radiolabeled ligands may affect the immune response, so people with active and clinically significant infections may become too immunocompromised through participation in this study.\n* Known brain metastases and\u002For carcinomatous meningitis unless these metastases have been treated and stabilized.\n* Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prior external beam radiation therapy involving \\>25% of the bone marrow.\n* Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.\n* Is unwilling or unable to establish care with a local provider outside of NIH CC\n* Inability to understand or unwilling to sign a written informed consent document.","ALL","18 Years","100 Years",{"count":85,"type":86},18,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","Background:\n\nOncocytic (Hurthle cell) thyroid cancer (HTC) is a rare disease with few treatment options. Researchers are developing a radioactive drug that targets a protein that appears in high numbers on HTC cancer cells.\n\nObjective:\n\nTo test a radioactive drug (177LuDOTA-EB-TATE) in people with HTC.\n\nEligibility:\n\nPeople aged 18 years and older with HTC. The HTC must have failed to respond to conventional radioactive treatment; it must also have spread to other parts of the body.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function.\n\n177LuDOTA-EB-TATE is infused into a vein. Participants will receive 4 infusions spaced 8 to 12 weeks apart. They will stay in the hospital for 4 to 10 days after each infusion. During and after each infusion, participants will remain in a lead-lined room until their radiation levels go down; this usually takes about 24 hours.\n\nParticipants will have 4 to 6 follow-up visits in the weeks after each infusion. Procedures will vary at each visit, but may include more imaging scans; blood and urine tests; and tests of heart function. Participants will have 2 single-photon emission computerized tomography (SPECT) scans. SPECT scans show where the study drug is sticking to tumors or maybe other parts of their body. They will lie on a table while a machine rotates around them. Participants will fill in questionnaires about how their thyroid condition affects their life.\n\nParticipants will have follow-ups visits for 5 years after their last study treatment.",[93],"Thyroid Cancer",[93,95,9],"H(SqrRoot) rthle cell thyroid cancer","NOT_YET_RECRUITING","2026-07-10",{"date":99,"type":100},"2026-07-13","ACTUAL",{"date":102,"type":86},"2026-07-16",{"date":104,"type":86},"2032-08-01",{"name":41,"class":6},1]