Congenital Hyperinsulinism study: 18F-DOPA vs Furosemide Injection
Official title 18F-DOPA II - PET Imaging Optimization
ClinicalTrials.gov ID: NCT04706910
What this study is testing
What is 18F-DOPA?
This is an investigational radioactive tracer being studied to help doctors see certain health conditions in the body. It is designed to act like a natural body chemical so it can be tracked by a special camera to show how specific tissues are working.
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
- The study aims to find the best way to take these PET scans to get clear images. It also looks at how the scan shows activity in the gallbladder.
- Who it's for
- The study is looking for children and adults with conditions such as brain tumors, neuroblastoma, neuroendocrine tumors, Parkinson's disease, Lewy body dementia, or congenital hyperinsulinism.
- What's involved
- Participants will receive a special PET/CT scan. This is a type of imaging test that uses a small amount of radioactive material to create detailed pictures of the body.
- Time commitment
- The study involves a single visit for the imaging scan.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Edmonton, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.