AzTrials
AzTrials

Congenital Hyperinsulinism (CHI)Phase 218FDOPANCT01468454

Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia

A Phase 2 study testing 18 F-DOPA in people with Congenital Hyperinsulinism (CHI) and Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI), run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism… Read more about this study

Who is it for?
Any age
What is being tested?
18 F-DOPA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
Jan 2009to Feb 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy

Who cannot join

  • Pregnant or lactating females
  • Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase II Safety and Efficacy Study of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Children With Hyperinsulinemic Hypoglycemia

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.

Read the detailed description

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). Children who have focal disease located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by these cells and used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will validate the efficacy and safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in children with hyperinsulinism.

Being tested
18 F-DOPA
Keywords
Congenital Hyperinsulinism (CHI), hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI), CHI, PHHI, Pancreatectomy, 18F-DOPA, PET/CT scan
Medical subject headings
Congenital Hyperinsulinism, Hyperinsulinism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18 F-DOPADrug

    Also called 18FDOPA PET SCAN

    1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA

Study groups in NCT01468454
Study groupRoleWhat they receive
(18F-DOPA) PET/CT imagingExperimentalObtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion
Receives: Drug: 18 F-DOPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism

    To determine the sensitivity and specificity of 18F-DOPA PET/CT for the detection of a focal pancreatic lesion in infants and children with poorly controlled hyperinsulinemic hypoglycemia.

    Measured: Surgery typically occured within a week post PET

Secondary outcomes (1)

  1. Safety of 18F-DOPA PET/CT Scan - Number of Participants With Adverse Events

    To further evaluate the safety of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET/CT imaging in infants and children with congenital hyperinsulinism

    • subjects are monitored clinically for any signs or symptoms of adverse events for 72 hours post PET. Adverse events are documented and followed to resolution

    Measured: evaluated with 72 hours or prior to pancreatic surgery (if any)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2011 (estimated)
  2. Study startJan 2009
  3. Primary completionJun 2014
  4. Study completionFeb 2018

Resources

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01468454
Sponsor's protocol ID
08-006211
Acronym
18FDOPA
Status last verified
Oct 2022
First submitted
18 Oct 2011
Last updated
13 Oct 2022
Data monitoring committee
No

Publications

  • Hardy OT, Hernandez-Pampaloni M, Saffer JR, Suchi M, Ruchelli E, Zhuang H, Ganguly A, Freifelder R, Adzick NS, Alavi A, Stanley CA. Diagnosis and localization of focal congenital hyperinsulinism by 18F-fluorodopa PET scan. J Pediatr. 2007 Feb;150(2):140-5. doi: 10.1016/j.jpeds.2006.08.028.

    PubMed 17236890

  • Hardy OT, Hernandez-Pampaloni M, Saffer JR, Scheuermann JS, Ernst LM, Freifelder R, Zhuang H, MacMullen C, Becker S, Adzick NS, Divgi C, Alavi A, Stanley CA. Accuracy of [18F]fluorodopa positron emission tomography for diagnosing and localizing focal congenital hyperinsulinism. J Clin Endocrinol Metab. 2007 Dec;92(12):4706-11. doi: 10.1210/jc.2007-1637. Epub 2007 Sep 25.

    PubMed 17895314

  • Hardy OT, Litman RS. Congenital hyperinsulinism - a review of the disorder and a discussion of the anesthesia management. Paediatr Anaesth. 2007 Jul;17(7):616-21. doi: 10.1111/j.1460-9592.2007.02192.x.

    PubMed 17564642

  • Peranteau WH, Ganguly A, Steinmuller L, Thornton P, Johnson MP, Howell LJ, Stanley CA, Adzick NS. Prenatal diagnosis and postnatal management of diffuse congenital hyperinsulinism: a case report. Fetal Diagn Ther. 2006;21(6):515-8. doi: 10.1159/000095664. Epub 2006 Sep 12.

    PubMed 16969006

  • Chevalme, Yanna-Marina et al. FDOPA-(18F): a PET radiopharmaceutical recently registered for diagnostic use in countries of the European Union. Braz. arch. biol. technol. [online]. 2007, vol.50, n.spe [cited 2011-10-06], pp. 77-90 . Available from: <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132007000600009&lng=en&nrm=iso>. ISSN 1516-8913. http://dx.doi.org/10.1590/S1516-89132007000600009.

  • Laje P, States LJ, Zhuang H, Becker SA, Palladino AA, Stanley CA, Adzick NS. Accuracy of PET/CT Scan in the diagnosis of the focal form of congenital hyperinsulinism. J Pediatr Surg. 2013 Feb;48(2):388-93. doi: 10.1016/j.jpedsurg.2012.11.025.

    PubMed 23414871

  • Laje P, Palladino AA, Bhatti TR, States LJ, Stanley CA, Adzick NS. Pancreatic surgery in infants with Beckwith-Wiedemann syndrome and hyperinsulinism. J Pediatr Surg. 2013 Dec;48(12):2511-6. doi: 10.1016/j.jpedsurg.2013.05.016.

    PubMed 24314195

  • Peranteau WH, Palladino AA, Bhatti TR, Becker SA, States LJ, Stanley CA, Adzick NS. The surgical management of insulinomas in children. J Pediatr Surg. 2013 Dec;48(12):2517-24. doi: 10.1016/j.jpedsurg.2013.04.022.

    PubMed 24314196

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18 F-DOPA in people with Congenital Hyperinsulinism (CHI) and Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI), run by Children's Hospital of Philadelphia at 1 site in United States.

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 1 inclusion and 2 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 13 Oct 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism (time frame: Surgery typically occured within a week post PET). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468454, which also lists 8 linked publications.

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 13 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in