[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350346":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":77,"collaborators":27,"id":79,"slug":27,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":27,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":27,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":59,"whyStopped":27,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"124I PET\u002FCT scan after rhTSH","ACTIVE_COMPARATOR","124I PET\u002FCT scan after preparation with human recombinant TSH",[13,14,15],"Drug: Thyrogen","Radiation: I-131","Radiation: I-124",{"label":17,"type":10,"description":18,"interventionNames":19},"124I PET\u002FCT scan after thyroid hormone withdrawal","124I PET\u002FCT scan after preparation with thyroid hormone withdrawal",[14,15,20],"Other: Thyroid hormone withdrawal",[22,28,33,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Thyrogen","intramuscular injection administered once\u002Fday for 2 consecutive days at Week 3; then once annually for subjects who meet criteria.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"RADIATION","I-131","therapeutic dose administered orally to treat thyroid cancer at Week 8. 5-7 days later, the post-treatment I-131 Whole Body scan w\u002F SPECT is performed; then administered once annually, if the patient needs to be re-treated",[9,17],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"I-124","one capsule ingested orally once at Week 3, and Week 8; then administered once annually to subjects who meet criteria.",[9,17],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":27},"OTHER","Thyroid hormone withdrawal","withdrawal of thyroid hormone during weeks 4 through 8",[17],[43],{"name":44,"affiliation":45,"role":46},"Joanna Klubo-Gwiezdzinska, M.D.","National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":27,"email":52},"Padmasree Veeraraghavan, R.N.","CONTACT","(301) 451-7710","padmasree.veeraraghavan@nih.gov",{"name":44,"role":50,"phone":54,"phoneExt":27,"email":55},"(301) 496-5052","joanna.klubo-gwiezdzinska@nih.gov",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-77.10026,38.98067,{"lat":69,"lon":68},[72],{"name":73,"role":50,"phone":74,"phoneExt":75,"email":76},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY8664111010","prpl@cc.nih.gov",{"type":78,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100350346",false,"NCT03841617","The Use of 124-I-PET\u002FCT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer","* INCLUSION CRITERIA:\n* Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who:\n\n  * underwent total thyroidectomy plus or minus neck lymph node dissection as clinically indicated,\n  * are presenting with known per structural imaging (US neck, CT or MRI neck\u002Fchest\u002Fabdomen\u002Fpelvis) persistent\u002Frecurrent disease either locally advanced or presenting with distant metastases; or\n  * are presenting with suspected persistent\u002Frecurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size \\>4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and\u002For lateral neck), detectable\u002Fincreasing baseline\u002Fsuppressed thyroglobulin (Tg) level or detectable\u002Fincreasing anti-Tg antibody titers if anti-Tg antibodies are present.\n  * are either RAI -naive or requiring repeated RAI therapy for locally advanced disease or distant metastases or underwent therapy with BRAF inhibitor (dabrafenib or vemurafenib\\*) or selumetinib\\*\\* for at least 4 weeks that may re-induce RAI uptake.\n  * Underwent imaging with either a CT or MRI of the brain and spine with gadolinium contrast to screen for the brain\u002Fspine metastases.\n\n    * Age greater than or equal to 18 years of age.\n    * 24 hour urine iodine excretion of less than or equal to 150 micro grams\u002F24 hour.\n\n      * BRAF inhibitors are recommended by 2021 NCCN guidelines as one of the management options for BRAF mutant tumors(13,14)\n\n        * Selumetinib has an FDA orphan drug designation for adjuvant treatment of metastatic thyroid cancer to re-induce RAI uptake\n\nEXCLUSION CRITERIA:\n\n-Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to re-differentiation therapy.\n\n* Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal.\n* Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096.\n\n  * Pregnant or lactating women per self report.\n  * Adults who are incapable of providing informed consent.","ALL","18 Years","90 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Study rationale\n\nHigh risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exogenous by injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I activity utilized for treatment is either based on empiric fixed dosage choice or individually determined activity based on 131 I dosimetric calculations. Although dosimetry utilizing radioactive iodine isotope 131 I enables calculation of maximum safe dose, it does not estimate the tumoricidal activity necessary to destroy the metastatic lesions. The alternative radioactive isotope of iodine -124 I, used for positron emission tomography (PET) imaging, might be used for calculation not only the maximum safe131 I dose, but also to predict the absorbed dose in the metastatic lesions.\n\nStudy objectives\n\nThe primary objective of this study is to compare the 124 I -PET\u002FCT lesional and whole body dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid cancer under preparation with rhTSH and THW. The secondary objective is to evaluate the predicted by PET\u002FCT lesional uptake with the early response to therapy.\n\nStudy design\n\nThis is a phase 2 pilot prospective cohort study comparing the lesional and whole body dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH stimulation and followed for 5 years.\n\nInterventions\n\nEach study participant will undergo rhTSH and THW-aided 124 I-PET\u002FCT dosimetric evaluations and will be subsequently treated with THW-aided RAI activity based on dosimetric calculations enabling maximum safe dosage. The patients will be followed in 12+\u002F-3 months intervals for 5 years.\n\nSample size and population\n\nThis pilot study will include 30 patients with high risk differentiated thyroid cancer presenting with distant and\u002For loco-regional metastases.",[95],"Thyroid Cancer",[95,97,98,99,100],"PET\u002FCT","124-I","Radioiodine","Metastases","2026-07-01",{"date":103,"type":104},"2026-07-02","ACTUAL",{"date":106,"type":104},"2019-07-29",{"date":108,"type":89},"2035-11-01",{"name":45,"class":6},1]