Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-07 @ 4:14 AM
Study NCT ID:
NCT03324893
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FCH PET/MRI Parathyroid Localization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland', 'timeFrame': '1 month postoperatively', 'description': 'Value of \\[F-18\\]-FCH PET/MRI next to Ultrasound of the Neck and 99mTc-MIBI SPECT/CT in determining which of the four parathyroid glands\n\nReference standards:\n\n* Intra-operative location of the hyper functioning gland by inspection and post-operative pathological confirmation.\n* Determination of biochemical cure per usual standard of care: intraoperative PTH and calcium and PTH postoperatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['18F-fluorocholine', 'Positron-Emission Tomography', 'Hyperparathyroidism, Primary']}, 'descriptionModule': {'briefSummary': 'A prospective trial comparing the accuracy of \\[F-18\\]-FCH PET/MRI to US and 99mTc-MIBI SPECT/CT for pre-operative parathyroid localization in patients with primary hyperparathyroidism'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Biochemically proven primary hyperparathyroidism\n* Indication for parathyroidectomy as per institutional guidelines\n\nExclusion Criteria:\n\n* Contraindication for MRI as per current institutional guidelines.\n* Contraindication for Gadolinium injection as per current institutional guidelines.\n* Renal failure\n* Inability to lie supine for at least 45 minutes.\n* Any participant who is pregnant or breastfeeding.\n* Participants receiving erythropoietin (i.e. for hemochromatosis; might lead to false negative results due to stimulation of bone marrow metabolism)\n* Familial HPT syndromes\n* Participant currently being treated with any cytotoxic chemotherapy'}, 'identificationModule': {'nctId': 'NCT03324893', 'briefTitle': 'FCH PET/MRI Parathyroid Localization', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': '18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas', 'orgStudyIdInfo': {'id': '16-5153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[F18]-FCH PET/MRI', 'description': 'Patients with primary hyperparathyroidism planned for parathyroidectomy', 'interventionNames': ['Diagnostic Test: [F-18]-FCH PET/MRI']}], 'interventions': [{'name': '[F-18]-FCH PET/MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FCH PET/MRI', 'Fluorine-18 fluorocholine PET/MRI'], 'description': 'Subjects will undergo the \\[F-18\\]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.', 'armGroupLabels': ['[F18]-FCH PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'm5g 2c4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'UHN', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}