18F-DOPA II - PET Imaging Optimization

NCT04706910 | Recruiting Phase 3

• 1 other identifier: Pro00100294
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations:

1. 1.Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
2. 2.Pediatric patients (less than 18 years old) with neuroblastoma.
3. 3.Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
4. 4.Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
5. 5.Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.

Conditions

Congenital Hyperinsulinism; Neuroblastoma; Parkinson Disease; Lewy Body Disease; Neuroendocrine Tumors; Brain Tumor

Outcome Measures

Primary Outcomes (4)

• Minimum lesion detectibility (size)

  Measurement of size (mm) of the three smallest lesions

  Within 1 month of PET/CT scan

• Assessment of bladder activity

  Measurement of standardized uptake value (SUV) for urinary bladder activity

  Within 1 month of PET/CT scan

• Assessment of bladder activity artifact

  Subjective scoring (0-2 scale) of image artifact in pelvis related to bladder activity

  Within 1 month of PET/CT scan

• Minimum lesion detectability (SUV)

  Measurement of the standardized uptake value (SUV) of the three smallest lesions

  Within 1 month of PET/CT scan

Secondary Outcomes (2)

• Gallbladder activity pattern

  Within 3 months of PET/CT scan

• Gallbladder disease questionnaire

  At the time of enrollment

Study Arms (1)

18F-DOPA injection

EXPERIMENTAL

All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical

Drug: 18F-DOPA; Drug: Furosemide Injection

Interventions

18F-DOPA DRUG

All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study

Also known as: 18F-dihydroxyphenylalanine

18F-DOPA injection

Furosemide Injection DRUG

Some participants will receive an intravenous injection of furosemide (40mg, single dose)

Also known as: 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid

18F-DOPA injection

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 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.

You may not qualify if:

• Unable to obtain consent
• Weight \>225 kg (weight limitation of PET/CT scanner)
• Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session.
• Young pediatric patients (less than 13 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).
• Lack of intravenous access
• History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)
• Pregnancy

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

WC Mackenzie Health Science Centre / University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

MeSH Terms

Conditions

Congenital Hyperinsulinism; Neuroblastoma; Parkinson Disease; Lewy Body Disease; Neuroendocrine Tumors; Brain Neoplasms

Interventions

fluorodopa F 18; Furosemide; 4-chloro-N-(2-furylmethyl)-5-sulfamoylanthranilic acid

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; Dementia; Neurocognitive Disorders; Mental Disorders; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Jonathan Abele, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Abele, MD

CONTACT

1-780-407-6907; jabele@ualberta.ca

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: December 21, 2020
• First Posted: January 13, 2021
• Study Start: January 20, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)