Status:

RECRUITING

18F-DOPA II - PET Imaging Optimization

Lead Sponsor:

University of Alberta

Conditions:

Congenital Hyperinsulinism

Neuroblastoma

Eligibility:

All Genders

Phase:

PHASE3

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. Pediatric patients (less than 18 years old) with congenit...

Detailed Description

BACKGROUND AND RATIONALE 6-\[18F\]fluoro-dihydroxyphenylalanine (18F-DOPA) is a large neutral amino acid that resembles natural L-3.4-dihydroxyphenylalanine (L-DOPA) biochemically. L-DOPA is a precur...

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unable to obtain consent
  2. Weight >225 kg (weight limitation of PET/CT scanner)
  3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session.
  4. 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).
  5. Lack of intravenous access
  6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)
  7. Pregnancy

Key Trial Info

Start Date :

January 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT04706910

Start Date

January 20 2021

End Date

December 1 2027

Last Update

February 9 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

WC Mackenzie Health Science Centre / University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7