NCT00674440

Brief Summary

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
13.9 years until next milestone

Results Posted

Study results publicly available

November 9, 2022

Completed
Last Updated

November 9, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

May 5, 2008

Results QC Date

July 20, 2022

Last Update Submit

October 11, 2022

Conditions

Congenital HyperinsulinismHyperinsulinismPersistent Hyperinsulinemic Hypoglycemia of InfancyCHIPHHI

Keywords

Congenital HyperinsulinismHyperinsulinismPersistent Hyperinsulinemic Hypoglycemia of InfancyCHIPHHIF-DOPAL-fluoro-dihydroxyphenylalanine

Outcome Measures

Primary Outcomes (1)

  • The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism

    Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse

    up to 1 month post surgical intervention

Secondary Outcomes (1)

  • Safety of F-DOPA PET

    72 hours maximum or prior to pancreatic surgery

Study Arms (1)

Subjects who had PET and surgery

EXPERIMENTAL

Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.

Drug: F-DOPARadiation: PET scan

Interventions

F-DOPADRUG

0.08-0.16 mCi/kg once

Also known as: 18F-labeled L-fluorodeoxyphenylalanine, 18F-DOPA
Subjects who had PET and surgery
PET scanRADIATION
Subjects who had PET and surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any age, but primarily infants 0-6 months.
  • Children with confirmed diagnosis of congenital hyperinsulinism.

You may not qualify if:

  • Cases in which surgery will not be considered by parents or guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

  • 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.

    PMID: 17564642BACKGROUND

  • Otonkoski T, Nanto-Salonen K, Seppanen M, Veijola R, Huopio H, Hussain K, Tapanainen P, Eskola O, Parkkola R, Ekstrom K, Guiot Y, Rahier J, Laakso M, Rintala R, Nuutila P, Minn H. Noninvasive diagnosis of focal hyperinsulinism of infancy with [18F]-DOPA positron emission tomography. Diabetes. 2006 Jan;55(1):13-8.

    PMID: 16380471BACKGROUND

  • Ribeiro MJ, Boddaert N, Delzescaux T, Valayannopoulos V, Bellanne-Chantelot C, Jaubert F, Verkarre V, Nihoul-Fekete C, Brunelle F, Lonlay P. Functional imaging of the pancreas: the role of [18F]fluoro-L-DOPA PET in the diagnosis of hyperinsulinism of infancy. Endocr Dev. 2007;12:55-66. doi: 10.1159/000109605.

    PMID: 17923769BACKGROUND

  • Subramaniam RM, Karantanis D, Peller PJ. [18F]Fluoro-L-dopa PET/CT in congenital hyperinsulinism. J Comput Assist Tomogr. 2007 Sep-Oct;31(5):770-2. doi: 10.1097/RCT.0b013e318031f55c.

    PMID: 17895790BACKGROUND

  • Ribeiro MJ, Boddaert N, Bellanne-Chantelot C, Bourgeois S, Valayannopoulos V, Delzescaux T, Jaubert F, Nihoul-Fekete C, Brunelle F, De Lonlay P. The added value of [18F]fluoro-L-DOPA PET in the diagnosis of hyperinsulinism of infancy: a retrospective study involving 49 children. Eur J Nucl Med Mol Imaging. 2007 Dec;34(12):2120-8. doi: 10.1007/s00259-007-0498-y. Epub 2007 Jul 28.

    PMID: 17661030BACKGROUND

  • de Lonlay P, Simon-Carre A, Ribeiro MJ, Boddaert N, Giurgea I, Laborde K, Bellanne-Chantelot C, Verkarre V, Polak M, Rahier J, Syrota A, Seidenwurm D, Nihoul-Fekete C, Robert JJ, Brunelle F, Jaubert F. Congenital hyperinsulinism: pancreatic [18F]fluoro-L-dihydroxyphenylalanine (DOPA) positron emission tomography and immunohistochemistry study of DOPA decarboxylase and insulin secretion. J Clin Endocrinol Metab. 2006 Mar;91(3):933-40. doi: 10.1210/jc.2005-1713. Epub 2006 Jan 10.

    PMID: 16403819BACKGROUND

  • 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.

    PMID: 17895314RESULT

  • 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.

    PMID: 17236890RESULT

Related Links

MeSH Terms

Conditions

Congenital HyperinsulinismHyperinsulinism

Interventions

fluorodopa F 18Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypoglycemia

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Limitations and Caveats

Some subjects have atypical disease that is neither focal or diffuse. Rapid genetic test results were not available at the beginning of the study.

Results Point of Contact

Title
Lisa J. States, MD
Organization
Children's Hospital of Philadelphia/Perelman School of Medicine, University of Pennsylvania
states@chop.edu
267-425-7146

Study Officials

  • Lisa J States, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician/Radiologist

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

December 1, 2004

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

November 9, 2022

Results First Posted

November 9, 2022

Record last verified: 2022-10

Locations

US(1)