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New treatment option for Congenital Hyperinsulinism
Official title 18F-DOPA II - PET Imaging Optimization
ClinicalTrials.gov ID: NCT04706910
What this study is testing
What is 18F-DOPA?
18F-DOPA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for congenital hyperinsulinism.
Also referred to as 18F-dihydroxyphenylalanine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 congenital hyperinsulinism.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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 likely can't join 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...
- Lack of intravenous access
- History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.