Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT05534594
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018276', 'term': 'Carcinoma, Medullary'}, {'id': 'C536914', 'term': 'Thyroid cancer, medullary'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.', 'timeFrame': 'Up to 2 years', 'description': 'Patient- and lesion-based sensitivity.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.', 'timeFrame': 'Up to 2 years', 'description': 'Comparison of patient- and lesion-based sensitivity. Comparison of Standardized Uptake Values (SUVs).'}, {'measure': 'Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.', 'timeFrame': 'Up to 2 years', 'description': 'Assess the correlation between 18F-PSMA uptake and serum calcitonin (ng/L) values.'}, {'measure': 'Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.', 'timeFrame': 'Up to 2 years', 'description': 'Assess the correlation between 18F-PSMA uptake and serum CEA (ug/L) values.'}, {'measure': 'Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.', 'timeFrame': 'Up to 2 years', 'description': 'Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/L) values.'}, {'measure': 'Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.', 'timeFrame': 'Up to 2 years', 'description': 'Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSMA PET/CT', '18F-PSMA PET/CT', 'Fluorine-18 Labeled Prostate Specific Membrane Antigen', 'Prostate Specific Membrane Antigen', 'Thyroid Cancer', 'Medullary Thyroid Cancer', 'Medullary Thyroid Carcinoma'], 'conditions': ['Medullary Thyroid Cancer', 'Medullary Thyroid Carcinoma', 'Thyroid Carcinoma, Medullary', 'Thyroid Cancer, Medullary']}, 'descriptionModule': {'briefSummary': 'Rationale: In patients with medullary thyroid cancer (MTC), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. The currently most used tracer in clinical practice, F-18 labelled fluorodeoxyglucose (18F-FDG), does not accurately detect MTC tumors with an indolent growth rate. A new, complimentary tracer is warranted to detect different subtypes.\n\nObjective: The primary objective is to assess the feasibility of using the F-18 labelled prostate specific membrane antigen (18F-PSMA) PET/CT for (re)staging patients with medullary thyroid cancer. The secondary objective is to compare the ability to detect MTC with the 18F-PSMA PET/CT to that of the 18F-FDG PET/CT.\n\nStudy design: Prospective, single-centre, feasibility study.\n\nStudy population: Patients (18 years of age or older) with biochemically and cytological/histological confirmed MTC, for whom the indication of an 18F-FDG PET/CT for tumor staging has already been determined on clinical grounds.\n\nMain study parameters/endpoints: The primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18F-PSMA PET to detect MTC lesions in patients with cytologically/histologically confirmed disease. Secondarily, the performance of the 18F-PSMA PET will be compared to the 18F-FDG PET/CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Histological or cytological proven MTC\n* Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA)\n* Clinical indication for an 18F-FDG PET/CT\n* Able to follow instructions to participate in the study\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Patients with prostate cancer or renal cell carcinoma\n* Pregnant patients\n* Recent neck surgery (\\<3 months ago)'}, 'identificationModule': {'nctId': 'NCT05534594', 'acronym': 'MIMETIC', 'briefTitle': 'Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer', 'orgStudyIdInfo': {'id': '202200014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT', 'description': 'Only 1 arm exists in this study.\n\nPatients with Medullary Thyroid Cancer undergo a PET/CT after receiving the Fluorine-18 labeled prostate specific membrane antigen (18F-PSMA-1007) tracer intravenously. Each patient will undergo this process one time. Patients will receive 3 MBq/kg (+- 10%) in 8,3 ml (maximum 400 MBq). Waiting time after injection is 60 minutes. Scanning time is approximately 45 minutes.', 'interventionNames': ['Drug: 18F-PSMA-1007']}], 'interventions': [{'name': '18F-PSMA-1007', 'type': 'DRUG', 'otherNames': ['Fluorine-18 labeled prostate specific membrane antigen'], 'description': "As explained under 'Arms'.", 'armGroupLabels': ['Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}