Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT03042416
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2017-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044903', 'term': 'Congenital Hyperinsulinism'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043437', 'term': 'fluorodopa F 18'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate safety evaluation', 'timeFrame': 'Within 1 hour of injection', 'description': 'Clinical screen for adverse reactions to 18F-DOPA injection'}], 'secondaryOutcomes': [{'measure': 'Delayed safety evaluation', 'timeFrame': '10-14 days after injection', 'description': 'A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection'}, {'measure': 'Delayed safety evaluation - referring physician', 'timeFrame': '6 months after injection', 'description': 'Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection'}, {'measure': 'Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected', 'timeFrame': 'Within 3 days after injection', 'description': 'Scan interpreter will evaluate the distribution of tracer and comment if expected'}, {'measure': 'Perceived clinical benefit', 'timeFrame': '6 months after injection', 'description': 'Questionnaire for referring physician to assess perceived clinical benefit of scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-DOPA PET/CT'], 'conditions': ['Congenital Hyperinsulinism', 'Neuroblastoma', 'Neuroendocrine Tumors', 'Parkinson Disease', 'Brain Glioma']}, 'descriptionModule': {'briefSummary': "Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:\n\n1. Pediatric patients with congenital hyperinsulinism\n2. Pediatric patients with neuroblastoma\n3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor\n4. Adult patients with a clinical suspicion of Parkinson's disease\n5. Pediatric or Adult patients with primary brain tumors\n\nThis study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Pediatric patients (less than 17 years old) with congenital hyperinsulinism\n* 2\\. Pediatric patients (less than 17 years old) with neuroblastoma\n* 3\\. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas\n* 4\\. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.\n* 5\\. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors\n\nExclusion Criteria:\n\n* Unable to obtain consent\n* Weight \\> 250 kg (weight limitation of PET/CT scanner)\n* Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan\n* Young pediatric patients (less than 10 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist)\n* Pregnancy\n* Lack of intravenous access"}, 'identificationModule': {'nctId': 'NCT03042416', 'briefTitle': '18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': '18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety', 'orgStudyIdInfo': {'id': 'Pro00055342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-DOPA scan', 'description': '18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient).', 'interventionNames': ['Drug: 18F-DOPA']}], 'interventions': [{'name': '18F-DOPA', 'type': 'DRUG', 'description': '18F-DOPA intravenous injection single dose', 'armGroupLabels': ['18F-DOPA scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Jonathan T Abele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Health services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}