Actively Recruiting

Phase 3
All Genders
ID04706910

18F-DOPA II - PET Imaging Optimization

Led by University of Alberta · Updated on 2026-02-09

800

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the optimization of 18F-DOPA PET/CT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinson's disease or Lewy body dementia. The study aims to improve image quality using a new digital PET/CT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PET/CT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

CONDITIONS

Brief Title

18F-DOPA II - PET Imaging Optimization

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients under 18 years old with congenital hyperinsulinism
  • Pediatric patients under 18 years old with neuroblastoma
  • Pediatric (under 18) or adult patients (18 or older) with known or suspected neuroendocrine tumor
  • Adult patients (18 or older) with clinical suspicion of Parkinson's disease or Lewy body dementia
  • Pediatric (under 18) or adult patients (18 or older) with brain tumors
Not Eligible

You will not qualify if you...

  • Unable to provide consent
  • Weight over 225 kg due to scanner limitations
  • Adult patients unable to lie flat for 20-30 minutes during the PET/CT scan
  • Pediatric patients under 13 years unable to lie flat for 20-30 minutes and for whom sedation is contraindicated
  • Lack of intravenous access
  • History of cholecystectomy (excluded from dynamic abdomen sub-study only)
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and questionnaire

Diagnostic Evaluation

Duration - 1 day

Participants receive an intravenous injection of 18F-DOPA for PET/CT imaging to assess metabolic activity and image quality. Some participants will also receive an intravenous injection of furosemide prior to imaging to improve image quality in the pelvis. A subgroup undergoes dynamic imaging of the abdomen to evaluate gallbladder activity patterns.

1 visit (in-person) for PET/CT scan including possible dynamic imaging lasting up to one hour

Follow-up

Duration - Up to 3 months after the PET/CT scan

Participants' imaging results are analyzed to assess lesion detectability, bladder activity, image artifact, and gallbladder activity patterns. A questionnaire about gallbladder disease history is completed at enrollment and results are compared among participant groups.

No additional visits; analysis performed from collected imaging and questionnaire data

Trial Site Locations

Total: 1 location

1

WC Mackenzie Health Science Centre / University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

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Research Team

J

Jonathan Abele, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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