A Phase 2 interventional study of F-DOPA and PET scan in Congenital Hyperinsulinism, Hyperinsulinism and Persistent Hyperinsulinemic Hypoglycemia of Infancy, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Children's Hospital of Philadelphia · Phase 2, Interventional, and Diagnostic
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.
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; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.
46 studies on the registry are indexed under Congenital Hyperinsulinism; 7 are open to participants now.
This study's enrollment of 106 is above the median of 23 across 35 interventional studies indexed under Congenital Hyperinsulinism.
Browse Congenital Hyperinsulinism studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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-DOPA · Radiation: PET scan
0.08-0.16 mCi/kg once
Also known as: 18F-labeled L-fluorodeoxyphenylalanine, 18F-DOPA
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
Time frame: up to 1 month post surgical intervention
Safety of F-DOPA PET
Number of Participants with Adverse Events
Time frame: 72 hours maximum or prior to pancreatic surgery
From December 2004 to December 2008, the study team recruited and enrolled 106 subjects referred to the Congenital Hyperinsulinism Center at the Children's Hospital of Philadelphia who were potential candidates for partial pancreatectomy surgery if focal lesions were suspected and were able to be localized.
| Milestone | All Subjects Consented |
|---|---|
| Started | 106 |
| Completed | 95 |
| Not completed | 11 |
| Withdrew: Consented but not scanned (withdrawn due to genetics) | 1 |
| Withdrew: Did not have surgery, so unevaluable | 7 |
| Withdrew: Had atypical histology or had second pet scan after initial surgery - not counted twice | 3 |
Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse
| Participants | Subjects Who Had PET and Surgery |
|---|---|
| True Negatives (PET diffuse/surgery diffuse) | 40 |
| False negatives (PET diffuse/surgery focal): | 6 |
| False positives (PET focal/surgery diffuse): | 3 |
| True positives (PET focal/surgery focal): | 46 |
Number of Participants with Adverse Events
| Participants | All Subjects Who Had PET |
|---|---|
| Safety of F-DOPA PET | 0 |
Collected over Reviewed within 72 hours post PET or prior to pancreatic surgery (which ever was first).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects Who Had PET | 0/105 (0%) | 0/105 (0%) | 0/105 (0%) |
| Age, Categorical(Participants) | Subjects Who Consented |
|---|---|
| <=18 years | 106 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Subjects Who Consented |
|---|---|
| Female | 53 |
| Male | 53 |
| Ethnicity (NIH/OMB)(Participants) | Subjects Who Consented |
|---|---|
| Hispanic or Latino | 19 |
| Not Hispanic or Latino | 87 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Subjects Who Consented |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 73 |
| More than one race | 23 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Subjects Who Consented |
|---|---|
| United States | 94 |
| Canada | 7 |
| Israel | 1 |
| Brazil | 1 |
| Curacao | 1 |
| Iran | 1 |
| Saudi Arabia | 1 |
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia