Congenital HyperinsulinismPhase 3NCT03042416
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
A Phase 3 study testing 18F-DOPA in people with Congenital Hyperinsulinism and Neuroblastoma, run by University of Alberta at 1 site in Canada.
Trial summary
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor 4. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors
- What is being tested?
- 18F-DOPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jun 2017to 2 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Pediatric patients (less than 17 years old) with congenital hyperinsulinism
- 2. Pediatric patients (less than 17 years old) with neuroblastoma
- 3. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas
- 4. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.
- 5. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors
Who cannot join
- Unable to obtain consent
- Weight > 250 kg (weight limitation of PET/CT scanner)
- Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan
- Young pediatric patients (less than 10 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)
- Pregnancy
- Lack of intravenous access
Trial locations and contacts
1 site in 1 country.
About this study
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:
- Pediatric patients with congenital hyperinsulinism
- Pediatric patients with neuroblastoma
- Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor
- Adult patients with a clinical suspicion of Parkinson's disease
- Pediatric or Adult patients with primary brain tumors
This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma
- Being tested
- 18F-DOPA
- Keywords
- 18F-DOPA PET/CT
- Medical subject headings
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DOPADrug
18F-DOPA intravenous injection single dose
| Study group | Role | What they receive |
|---|---|---|
| 18F-DOPA scan | Experimental | 18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient). Receives: Drug: 18F-DOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate safety evaluation
Clinical screen for adverse reactions to 18F-DOPA injection
Measured: Within 1 hour of injection
Secondary outcomes (4)
Delayed safety evaluation
A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
Measured: 10-14 days after injection
Delayed safety evaluation - referring physician
Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection
Measured: 6 months after injection
Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected
Scan interpreter will evaluate the distribution of tracer and comment if expected
Measured: Within 3 days after injection
Perceived clinical benefit
Questionnaire for referring physician to assess perceived clinical benefit of scan
Measured: 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start29 Jun 2017
- Primary completion5 Mar 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HyperinsulinismStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Jonathan T Abele, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042416
- Sponsor's protocol ID
- Pro00055342
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2017
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
- ClinicalTrials.gov ID
- NCT03042416
- Acronym / sponsor ID
- Pro00055342
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma
- Keywords
- 18F-DOPA PET/CT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:
- Pediatric patients with congenital hyperinsulinism
- Pediatric patients with neuroblastoma
- Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor
- Adult patients with a clinical suspicion of Parkinson's disease
- Pediatric or Adult patients with primary brain tumors
This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-DOPA scan | Experimental | Drug: 18F-DOPA18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Pediatric patients (less than 17 years old) with congenital hyperinsulinism
- 2. Pediatric patients (less than 17 years old) with neuroblastoma
- 3. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas
- 4. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.
- 5. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors
Key exclusion criteria (6 listed)
- Unable to obtain consent
- Weight > 250 kg (weight limitation of PET/CT scanner)
- Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan
- Young pediatric patients (less than 10 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)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DOPA18F-DOPA intravenous injection single dose | Drug | 18F-DOPA scan |
Primary outcome
Immediate safety evaluation
Time frame: Within 1 hour of injection
Clinical screen for adverse reactions to 18F-DOPA injection
4 secondary outcomes
Delayed safety evaluation
Time frame: 10-14 days after injection
Delayed safety evaluation - referring physician
Time frame: 6 months after injection
Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected
Time frame: Within 3 days after injection
Perceived clinical benefit
Time frame: 6 months after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan T Abele, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-DOPA in people with Congenital Hyperinsulinism and Neuroblastoma, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate safety evaluation (time frame: Within 1 hour of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.