[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05024929":3,"trial-entities:NCT05024929":173,"trial-summary:NCT05024929":182},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":24,"healthy_volunteers":15,"eligibility_criteria":44,"std_ages":48,"locations":52,"central_contacts":166,"overall_officials":170,"references":171,"see_also_links":172},"NCT05024929","21-018612","Targeted Therapy to Increase RAI Uptake in Metastatic DTC","Targeted Therapy to Increase RAI Uptake in Patients With Metastatic Differentiated Thyroid Cancer","RECRUITING","2033-02-01","2025-11","2025-11-14","2021-07-16","Children's Hospital of Philadelphia","OTHER",false,"Papillary thyroid cancer (PTC) is a common type of differentiated thyroid cancer (DTC) in children and represents the second most common cancer in adolescent females. Recently targeted drugs that block many of the genetic drivers of DTC have become available. While Investigators know that these drugs shrink DTC tumors in many cases, the impact on radioactive iodine (RAI) avidity has not been systematically studied.","This is an observational cohort study that will enroll patients with DTC metastatic to the lungs who will receive oncogene-specific targeted therapy as part of routine clinical care or a separate therapeutic clinical trial. After approximately 4 weeks of therapy, patients will have a whole body scan to determine the change in RAI-avidity of their tumor from baseline. Subsequent therapy will be at the discretion of the treating physician or according to the therapeutic trial on which the patient is enrolled.",[19,20,21],"Papillary Thyroid Cancer","Pediatric Cancer","Differentiated Thyroid Cancer",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},32,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","Whole body scan","Patients will receive oncogene-specific molecularly targeted therapy independently of this protocol either via commercial supply of an FDA approved agent, or as part of a separate therapeutic clinical trial\u002Fcompassionate use protocol\u002Fsingle patient investigational new drug (IND).\n\nDuring screening, patients will undergo a baseline RAI-whole body scan (WBS) to assess RAI-avidity of their tumor per standard of care. Following approximately 28 days of targeted therapy, the WBS will be repeated to determine whether this therapy is associated with an increase in RAI-avidity of their tumor.",[35],"Prospective Cohort",[37],{"measure":38,"description":39,"timeFrame":40},"Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy","The primary outcome measure is to determine the proportion of patients with differentiated thyroid cancer metastatic to the lungs for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.","up to 5 years",[],"ALL","0 Years",{"inclusion":45,"exclusion":46,"raw_text":47},[],[],"Inclusion Criteria (Prospective Cohort):\n\n1. Patients with a histologic diagnosis of differentiated thyroid cancer\n2. Presence of an neurotrophic tyrosine kinase receptors (NTRK)-fusion, RET-fusion, anaplastic lymphoma kinase (ALK)-fusion, BRAF V600 mutation, BRAF-fusion or other targetable alteration identified in a Clinical Laboratory Improvement Amendments\u002FCollege of American Pathologists (CLIA\u002FCAP) laboratory\n3. Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):\n\n   1. multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and\u002For\n   2. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease\n4. Patients for whom systemic therapy with an oncogene-specific kinase inhibitor is planned from commercial supply or as part of a separate therapeutic clinical trial (that does not include data sharing with this protocol)\u002Fcompassionate access protocol\u002Fsingle patient investigational new drug (IND). Such agents include, but are not limited to:\n\n   1. Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions\n   2. Selpercatinib and pralsetinib for RET fusions\n   3. Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions\n   4. Dabrafenib and\u002For trametinib for BRAF V600 mutations\n   5. Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment\n\nInclusion Criteria (Data Sharing Cohort):\n\n1\\. Patients enrolled on other oncogene-specific targeted therapy trials who undergo whole body thyroid scan approximately 28 days after beginning targeted therapy and agree to data sharing as part of the consent process for that trial.\n\nExclusion Criteria (All Cohorts):\n\n1. No prior oncogene-specific targeted therapy allowed. However, patients may enroll within 4 weeks of starting oncogene-specific therapy if a pre-therapy WBS is available. Prior therapy with non-oncogene specific multi-thyrosine kinase inhibitors (such as sorafenib, lenvatinib, and\u002For cabozantanib) is allowed.\n2. Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus\u002Fneonate.\n3. Patients who require sedation\u002Fgeneral anesthesia to complete a WBS are excluded.\n4. U.S. Military Personnel are excluded due to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) requirements.",[49,50,51],"CHILD","ADULT","OLDER_ADULT",[53,70,81,94,112,123,135,143,155],{"facility":54,"status":8,"city":55,"state":56,"zip":57,"country":58,"contacts":59,"geoPoint":67},"University of California San Francisco","San Francisco","California","94143","United States",[60,65],{"name":61,"role":62,"phone":63,"email":64},"Arun Rangaswami, MD","CONTACT","415-298-9434","karina.wong@ucsf.edu",{"name":66,"role":62,"phone":63,"email":64},"Karina Wong",{"lat":68,"lon":69},37.77493,-122.41942,{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":58,"contacts":75,"geoPoint":78},"Emory University School of Medicine","Atlanta","Georgia","30322",[76],{"name":77,"role":62},"Brianna Patterson, MD",{"lat":79,"lon":80},33.749,-84.38798,{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":58,"contacts":86,"geoPoint":91},"Boston Children's Hospital","Boston","Massachusetts","02115",[87,89],{"name":88,"role":62},"Junne Kamihara, MD",{"name":88,"role":90},"PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},42.35843,-71.05977,{"facility":13,"status":8,"city":95,"state":96,"zip":97,"country":58,"contacts":98,"geoPoint":109},"Philadelphia","Pennsylvania","19104",[99,103,107],{"name":100,"role":62,"phone":101,"email":102},"Meghan T Donnelly","267-436-9343","donnellymt@chop.edu",{"name":104,"role":62,"phone":105,"email":106},"James Robinson","215-590-2053","robinsonj9@chop.edu",{"name":108,"role":90},"Theodore Laetsch, MD",{"lat":110,"lon":111},39.95238,-75.16362,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":58,"contacts":117,"geoPoint":120},"St. Jude Children's Research Hospital","Memphis","Tennessee","38105",[118],{"name":119,"role":62},"Sara Helmig, MD",{"lat":121,"lon":122},35.14953,-90.04898,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":58,"contacts":128,"geoPoint":132},"MD Anderson Cancer Center","Houston","Texas","77030",[129,131],{"name":130,"role":62},"Steven Waguespack, MD",{"name":130,"role":90},{"lat":133,"lon":134},29.76328,-95.36327,{"facility":136,"status":8,"city":125,"state":126,"zip":127,"country":58,"contacts":137,"geoPoint":142},"Texas Children's Hospital",[138,140],{"name":139,"role":62},"Rajkumar Venkatramani, MD",{"name":141,"role":90},"Priya Mahajan, MD",{"lat":133,"lon":134},{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":58,"contacts":148,"geoPoint":152},"Seattle Children's Hospital","Seattle","Washington","98105",[149,151],{"name":150,"role":62},"Tyler Ketterl, MD, MS",{"name":150,"role":90},{"lat":153,"lon":154},47.60621,-122.33207,{"facility":156,"status":8,"city":157,"state":158,"country":159,"contacts":160,"geoPoint":163},"Children's Hospital Westmead","Sydney","New South Wales","Australia",[161],{"name":162,"role":62},"Paul Benitez-Aguirre, MD",{"lat":164,"lon":165},-33.86785,151.20732,[167,169],{"name":100,"role":62,"phone":168,"email":102},"2674269343",{"name":104,"role":62,"phone":105,"email":106},[],[],[],{"nct_id":4,"conditions":174,"biomarkers":177},[175,176],"Differentiated Thyroid Gland Carcinoma","Thyroid Gland Papillary Carcinoma",[178,179,180,181],"ALK Gene","BRAF Gene","NTRK Family Gene","Proto-Oncogene Tyrosine-Protein Kinase Receptor Ret",{"nct_id":4,"found":183,"summary":184,"prompt_version":194},true,{"design":185,"status":186,"heading":187,"summary":188,"follow_up":189,"word_count":190,"commitments":191,"compensation":192,"drugs_mentioned":193},"This is an observational study with a planned enrollment of 32 patients. It is not specified if it is randomized or blinded.","completed","Targeted Therapy for RAI Uptake in Metastatic Differentiated Thyroid Cancer","This study is looking at how targeted therapies affect radioactive iodine (RAI) uptake in patients with metastatic differentiated thyroid cancer (DTC), including papillary thyroid cancer (PTC). These cancers often have specific genetic changes like NTRK-fusion, RET-fusion, ALK-fusion, or BRAF V600 mutation. You might be eligible if you have one of these genetic changes and are already receiving targeted therapy, either commercially or through another clinical trial. The study will observe if your tumor's ability to absorb RAI increases after about four weeks of targeted therapy. Researchers will measure this change with a whole body scan. The goal is to understand if these targeted treatments can make RAI more effective for shrinking tumors.","The study will measure the proportion of patients with increased tumor RAI-avidity for up to 5 years.",112,"You will receive targeted therapy as part of your routine care or another trial. After about four weeks, you will have a whole body scan to check for changes in radioactive iodine uptake.","Not stated in the trial record.",[32],"v2"]