Congenital Hyperinsulinism International

Clinical Research Trials

A clinical research trial is a research project conducted with human volunteers to learn more about new investigational drugs. Every new therapy or device must go through carefully monitored studies in human volunteers before it is commercially available. The clinical trials linked below are currently enrolling congenital hyperinsulinism (HI) patients.

The HI community needs new therapies and approaches for patients who do not respond to currently available treatments, and clinical trials that safeguard the health of study participants are necessary for the development of new HI products. The website www.clinicaltrials.gov “is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.” You can learn more about this site by visiting it.

The U.S. National Institute of Health (NIH) has a very good website on clinical trial participation. Please visit: www.nih.gov/health-information/nih-clinical-research-trials-you

Linked below are clinical trials listed on the www.clinicaltrials.gov site that are relevant to the HI Community.

Each of the studies listed below has a Contact and Locations link with information about who to contact and the location of the study site.

The HI studies are listed below:

Potential new Treatment studies include –

Sirolimus for the Treatment of Hyperinsulinism

CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism

Effect of Exendin-(9-39) On Glucose Requirements To Maintain Euglycemia

Pasireotide in Hyperinsulinemic Hypoglycemia

Diagnostic imaging studies:

These studies, involving 18-Fluoro DOPA and 68Ga-NOTA-exendin-4 PET/CT, are for diagnostic purposes to determine location of lesions, and are not studies on new investigational medications for treating HI.

18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

Fluorodopa F 18 in Congenital Hyperinsulinism

18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia ([18F]-DOPA)

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