Phase 2 N=128 Diagnostic

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01468454 ↗

Enrolled (actual)

128

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism — 34; 10; 4; 52 cases

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 18 F-DOPA (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism	34; 10; 4; 52	—
SECONDARY Safety of 18F-DOPA PET/CT Scan - Number of Participants With Adverse Events	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01468454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.