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

NCT01468454 | Completed Phase 2 Results

• 1 other identifier: 08-006211
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Congenital Hyperinsulinism (CHI); Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)

Keywords

Congenital Hyperinsulinism (CHI); hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI); CHI; PHHI; Pancreatectomy; 18F-DOPA; PET/CT scan

Outcome Measures

Primary Outcomes (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.

  Surgery typically occured within a week post PET

Secondary Outcomes (1)

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

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

Study Arms (1)

(18F-DOPA) PET/CT imaging

EXPERIMENTAL

Obtain 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

Drug: 18 F-DOPA

Interventions

18 F-DOPA DRUG

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

Also known as: 18FDOPA PET SCAN

(18F-DOPA) PET/CT imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

• 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: 17236890 BACKGROUND

• 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: 17895314 BACKGROUND

• 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: 17564642 BACKGROUND

• 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.

  PMID: 16969006 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23414871 RESULT

• 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.

  PMID: 24314195 RESULT

• 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.

  PMID: 24314196 RESULT

Related Links

• The Congenital Hyperinsulinism Center at The Children's Hospital of Philadelphia

MeSH Terms

Conditions

Congenital Hyperinsulinism; Hyperinsulinism

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia

Results Point of Contact

• Title: Lisa J. States, MD
• Organization: Children's Hospital of Philadelphia - Department of Radiology

states@chop.edu

267-245-7146

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: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 9, 2011
• Study Start: January 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2018
• Last Updated: October 13, 2022
• Results First Posted: October 15, 2021

Record last verified: 2022-10

Locations

US (1)