18F-DOPA II - PET Imaging Optimization
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|ClinicalTrials.gov Identifier: NCT04706910|
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 13, 2022
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations:
- Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
- Pediatric patients (less than 18 years old) with neuroblastoma.
- Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
- Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
- Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.
Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Hyperinsulinism Neuroblastoma Parkinson Disease Lewy Body Disease Neuroendocrine Tumors Brain Tumor||Drug: 18F-DOPA Drug: Furosemide Injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F-DOPA II - PET Imaging Optimization|
|Actual Study Start Date :||January 20, 2021|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||July 2026|
Experimental: 18F-DOPA injection
All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical
All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study
Other Name: 18F-dihydroxyphenylalanine
Drug: Furosemide Injection
Some participants will receive an intravenous injection of furosemide (40mg, single dose)
Other Name: 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid
- Minimum lesion detectibility (size) [ Time Frame: Within 1 month of PET/CT scan ]Measurement of size (mm) of the three smallest lesions
- Assessment of bladder activity [ Time Frame: Within 1 month of PET/CT scan ]Measurement of standardized uptake value (SUV) for urinary bladder activity
- Assessment of bladder activity artifact [ Time Frame: Within 1 month of PET/CT scan ]Subjective scoring (0-2 scale) of image artifact in pelvis related to bladder activity
- Minimum lesion detectability (SUV) [ Time Frame: Within 1 month of PET/CT scan ]Measurement of the standardized uptake value (SUV) of the three smallest lesions
- Gallbladder activity pattern [ Time Frame: Within 3 months of PET/CT scan ]Assessment of SUVmax of various segments of the biliary tree at different time points after 18F-DOPA injection using a subgroup of participants (64 total)
- Gallbladder disease questionnaire [ Time Frame: At the time of enrollment ]All participants will complete a questionnaire regarding a history of gallbladder disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706910
|Contact: Jonathan Abele, MDfirstname.lastname@example.org|
|WC Mackenzie Health Science Centre / University of Alberta Hospital||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Contact: Jonathan Abele, MD 780-407-6907 email@example.com|
|Principal Investigator:||Jonathan Abele, MD||University of Alberta|