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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03042416
Other study ID # Pro00055342
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 29, 2017
Est. completion date June 2, 2021

Study information

Verified date January 2022
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor 4. Adult patients with a clinical suspicion of Parkinson's disease 5. Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 2, 2021
Est. primary completion date March 5, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 1. Pediatric patients (less than 17 years old) with congenital hyperinsulinism - 2. Pediatric patients (less than 17 years old) with neuroblastoma - 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 - 4. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease. - 5. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors Exclusion Criteria: - Unable to obtain consent - Weight > 250 kg (weight limitation of PET/CT scanner) - Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan - 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) - Pregnancy - Lack of intravenous access

Study Design


Intervention

Drug:
18F-DOPA
18F-DOPA intravenous injection single dose

Locations

Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Alberta Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immediate safety evaluation Clinical screen for adverse reactions to 18F-DOPA injection Within 1 hour of injection
Secondary Delayed safety evaluation A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection 10-14 days after injection
Secondary Delayed safety evaluation - referring physician Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection 6 months after injection
Secondary 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
Secondary Perceived clinical benefit Questionnaire for referring physician to assess perceived clinical benefit of scan 6 months after injection
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