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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
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Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:
This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DOPA scan | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DOPA | Drug | 18F-DOPA intravenous injection single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate safety evaluation | Clinical screen for adverse reactions to 18F-DOPA injection | Within 1 hour of injection |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed safety evaluation | A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection | 10-14 days after injection |
| Delayed safety evaluation - referring physician | Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan T Abele, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G2B7 | Canada |
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| ID | Term |
|---|---|
| D044903 | Congenital Hyperinsulinism |
| D009447 | Neuroblastoma |
| D018358 | Neuroendocrine Tumors |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C043437 | fluorodopa F 18 |
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| 6 months after injection |
| Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected | Scan interpreter will evaluate the distribution of tracer and comment if expected | Within 3 days after injection |
| Perceived clinical benefit | Questionnaire for referring physician to assess perceived clinical benefit of scan | 6 months after injection |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007003 | Hypoglycemia |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |