Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-27 @ 10:15 AM
Study NCT ID:
NCT06443866
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification and characterization of RAI uptake pattern and kinetics', 'timeFrame': '5 years', 'description': 'Measurements:\n\n1. Administered activity\n2. Cumulated activity\n3. Standard uptake value\n\nCalculations:\n\n1\\. Radiation absorbed dose to the target\n\nCorrelations to be reported:\n\n1. Administered activity vs absorbed dose\n2. Absorbed dose vs response\n3. SUV at 48h vs response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Thyroid Cancer', 'RAI-Refractory Thyroid Cancer', 'Redifferentiation Therapy'], 'conditions': ['Thyroid Cancer', 'RAI-Refractory Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI).\n\nPatients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18 and older) with thyroid cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease\n* Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\\|CT or elevated thyroglobulin (Tg).\n* Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI\n* Age ≥ 18\n* Ability and willingness to give a written consent\n* Life expectancy \\> 3 months\n* ECOG performance status ≤ 2\n\nExclusion Criteria\n\n* Cancers metastatic to thyroid\n* Age \\< 18\n* Inability or unwillingness to give a written consent\n* Life expectancy \\< 3 months\n* ECOG performance status ≥ 3\n* Pregnant and nursing women.'}, 'identificationModule': {'nctId': 'NCT06443866', 'briefTitle': 'I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Miami Cancer Research Center, Inc.'}, 'officialTitle': 'CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER', 'orgStudyIdInfo': {'id': 'MTOCP03'}, 'secondaryIdInfos': [{'id': 'MBK funding', 'type': 'OTHER', 'domain': 'MiamiCancerRC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thyroid Cancer patients, RAI-naive or refractory', 'interventionNames': ['Diagnostic Test: Disease status detection', 'Diagnostic Test: Theranostic dosimetry', 'Drug: I-124 PET/CT imaging']}], 'interventions': [{'name': 'Disease status detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'RAI dose determination', 'armGroupLabels': ['Thyroid Cancer patients, RAI-naive or refractory']}, {'name': 'Theranostic dosimetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer', 'armGroupLabels': ['Thyroid Cancer patients, RAI-naive or refractory']}, {'name': 'I-124 PET/CT imaging', 'type': 'DRUG', 'description': 'Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer', 'armGroupLabels': ['Thyroid Cancer patients, RAI-naive or refractory']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33181', 'city': 'North Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seza Gulec, MD', 'role': 'CONTACT', 'email': 'sezagulec@gmail.com', 'phone': '786-693-0821'}], 'facility': 'Miami Cancer Research Center', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}], 'centralContacts': [{'name': 'Seza Gulec, MD', 'role': 'CONTACT', 'email': 'sezagulec@gmail.com', 'phone': '786-693-0821'}, {'name': 'Keila Rios', 'role': 'CONTACT', 'phone': '786-487-3230'}], 'overallOfficials': [{'name': 'Seza Gulec, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEO, MCRC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miami Cancer Research Center, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}