Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 12:57 PM
Study NCT ID:
NCT04570033
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010282', 'term': 'Parathyroid Neoplasms'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas', 'timeFrame': '24 months', 'description': 'Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'fluorocholine'], 'conditions': ['Hyperparathyroidism', 'Parathyroid Adenoma']}, 'referencesModule': {'references': [{'pmid': '22089066', 'type': 'RESULT', 'citation': 'Cordellat IM. Hyperparathyroidism: primary or secondary disease? Reumatol Clin. 2012 Sep-Oct;8(5):287-91. doi: 10.1016/j.reuma.2011.06.001. Epub 2011 Oct 20.'}, {'pmid': '27532368', 'type': 'RESULT', 'citation': 'Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.'}, {'pmid': '31919634', 'type': 'RESULT', 'citation': 'Lopez-Mora DA, Sizova M, Estorch M, Flotats A, Camacho V, Fernandez A, Abouzian S, Fuentes-Ocampo F, Garcia JIP, Ballesteros AIC, Duch J, Domenech A, Duarte AM, Carrio I. Superior performance of 18F-fluorocholine digital PET/CT in the detection of parathyroid adenomas. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):572-578. doi: 10.1007/s00259-020-04680-7. Epub 2020 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).', 'detailedDescription': 'We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary hyperparathyroidism and neck US and the dual-phase 99mTc/99mTc-MIBI SPECT/CT scintigraphy performed prior to the PET/CT scan\n\nExclusion Criteria:\n\n* pregnancy\n* patient's lack of consent to the examination"}, 'identificationModule': {'nctId': 'NCT04570033', 'briefTitle': 'The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas', 'orgStudyIdInfo': {'id': 'Military Institute of Medicine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with hyperparathyroidism', 'description': 'We prospectively enrolled 65 consecutive patients with primary hyperparathyroidism (PHPT) who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study', 'interventionNames': ['Diagnostic Test: We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism']}], 'interventions': [{'name': 'We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism', 'type': 'DIAGNOSTIC_TEST', 'description': 'We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.', 'armGroupLabels': ['patients with hyperparathyroidism']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrzej Mazurek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Warsaw', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Andrzej Mazurek', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}