18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

NCT03042416 | Completed Phase 3

• 1 other identifier: Pro00055342
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:

1. 1.Pediatric patients with congenital hyperinsulinism
2. 2.Pediatric patients with neuroblastoma
3. 3.Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor
4. 4.Adult patients with a clinical suspicion of Parkinson's disease
5. 5.Pediatric or Adult patients with primary brain tumors

Conditions

Congenital Hyperinsulinism; Neuroblastoma; Neuroendocrine Tumors; Parkinson Disease; Brain Glioma

Keywords

18F-DOPA PET/CT

Outcome Measures

Primary Outcomes (1)

• Immediate safety evaluation

  Clinical screen for adverse reactions to 18F-DOPA injection

  Within 1 hour of injection

Secondary Outcomes (4)

• Delayed safety evaluation

  10-14 days after injection

• Delayed safety evaluation - referring physician

  6 months after injection

• Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected

  Within 3 days after injection

• Perceived clinical benefit

  6 months after injection

Study Arms (1)

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).

Drug: 18F-DOPA

Interventions

18F-DOPA DRUG

18F-DOPA intravenous injection single dose

18F-DOPA scan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Pediatric patients (less than 17 years old) with congenital hyperinsulinism
• \. Pediatric patients (less than 17 years old) with neuroblastoma
• \. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas
• \. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.
• \. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Congenital Hyperinsulinism; Neuroblastoma; Neuroendocrine Tumors; Parkinson Disease

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jonathan T Abele, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: June 29, 2017
• Primary Completion: March 5, 2021
• Study Completion: June 2, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)