Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT05175404
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2021-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2021-12-30', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate uptake of 18F-PSMA-11 in RAI-RTC', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11', 'description': 'Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.'}], 'secondaryOutcomes': [{'measure': 'Perform a semi-quantitative analysis of radiotracer uptake in lesions.', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11'}, {'measure': 'Perform a lesion detection rate analysis on organ level.', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11'}, {'measure': 'Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11'}, {'measure': 'Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11'}, {'measure': 'Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11'}, {'measure': 'Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET', 'timeFrame': '60 minutes +- 5 minutes after injection 18F-PSMA-11'}, {'measure': 'Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.', 'timeFrame': 'Within 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '39264376', 'type': 'RESULT', 'citation': 'Van den Broeck B, Debacker JM, Bauters W, Creytens D, Ferdinande L, Huvenne W, Lapauw B, Schelfhout V, Van Laeken N, Verroken C. Potential application of [18F]AlF-PSMA-11 PET/CT in radioiodine refractory thyroid carcinoma. EJNMMI Res. 2024 Sep 12;14(1):82. doi: 10.1186/s13550-024-01148-9.'}]}, 'descriptionModule': {'briefSummary': 'Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years or older.\n* Signed Informed Consent.\n* Subject is diagnosed with a histologically confirmed differentiated thyroid carcinoma, that is considered RAI refractory. There is evidence of persisting or recurrent disease, based on serum thyroglobulin levels and/or medical imaging.\n* Subject should have a routine clinical 18F-FDG PET/CT performed within two months prior to the study scan.\n* Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives (methods that can achieve a failure rate of less than 1%: combined hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).\n\nExclusion Criteria:\n\n* Patient has a known other active malignancy.\n* Subject is potentially pregnant (urinary test can be performed in case of doubt) or breastfeeding.\n* Patient is mentally or legally incapacitated.'}, 'identificationModule': {'nctId': 'NCT05175404', 'briefTitle': 'Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers', 'orgStudyIdInfo': {'id': 'BC-09501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Overal Trial', 'description': 'only one arm in this trial', 'interventionNames': ['Diagnostic Test: PET/CT scan F18-PSMA-11']}], 'interventions': [{'name': 'PET/CT scan F18-PSMA-11', 'type': 'DIAGNOSTIC_TEST', 'description': 'PET/CT scan with F18-PSMA-11', 'armGroupLabels': ['Overal Trial']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}