Testing 18F-DOPA with Furosemide for congenital hyperinsulinism
Official title: 18F-DOPA II - PET Imaging Optimization
- Phase 3
- 1 group
- One site, in Edmonton
- Recruiting
Interventions
- Medication
18F-DOPA
All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study
- Medication
Furosemide Injection
Some participants will receive an intravenous injection of furosemide (40mg, single dose)
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
WC Mackenzie Health Science Centre / University of Alberta Hospital
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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.
Exclusion
- −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).
- −Unable to obtain consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Weight \>225 kg (weight limitation of PET/CT scanner)
- −Lack of intravenous access
- −History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study receives 18F-DOPA, together with one or more of: Furosemide Injection.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 800 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Within 1 month of PET/CT scan.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Minimum lesion detectibility (size) — measured over Within 1 month of PET/CT scan.
Assessment of bladder activity — measured over Within 1 month of PET/CT scan.
Assessment of bladder activity artifact — measured over Within 1 month of PET/CT scan.
Minimum lesion detectability (SUV) — measured over Within 1 month of PET/CT scan.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04706910 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 18F-DOPADrug
All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Furosemide InjectionDrug
Some participants will receive an intravenous injection of furosemide (40mg, single dose)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 1 month of PET/CT scan.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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. 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. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.