Hyperinsulinism Clinical Trial
— 18FDOPA HIOfficial title:
Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism
Verified date | July 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET/MRI as a preoperative tool to detect and localize focal lesions in the pancreas that are causing hyperinsulinism.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 1, 2030 |
Est. primary completion date | January 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation. 2. Subjects who failed pharmacological therapy with diazoxide or octreotide. 3. Subjects with signed informed consent by themselves or their parents or legal guardians. 4. Patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended to prevent future episodes of severe hypoglycemia and preserve brain function. Exclusion Criteria: 1. Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study. 2. Patient must not have any contraindication to MRI as evaluated by a standardized MRI safety questionnaire. If MRI is contraindicated, and patient meets inclusion criteria and has no other contraindications study will be conducted in PET/CT scanner. 3. Cases in which surgery will not be considered by parents or guardians. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | St. Louis Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy | To provide access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who do not respond to pharmacological therapy and are being considered for pancreatic surgery. We will measure this by totaling the number of scans performed yearly. | one year | |
Secondary | Accuracy of 18FDOPA PET/MRI to identify focal forms of hyperinsulinism that may be cured by surgery | To identify if data from 18FDOPA PET/MRI imaging can accurately diagnose focal forms of HI when compared to the gold-standard of histopathological findings obtained at surgery in subjects who received a partial or complete pancreatectomy. Currently this type of isotope is not available for diagnosis, of insulinomas. | one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00073775 -
Epidemiology of Stress and the Metabolic Syndrome
|
N/A | |
Completed |
NCT00074451 -
Genomewide Search for Loci Underlying Metabolic Syndrome
|
||
Completed |
NCT00005380 -
Insulin, Androgen, and Risk in African-American Women
|
N/A | |
Completed |
NCT00005709 -
Lipoprotein Metabolism in Hypertensive African-Americans
|
N/A | |
Not yet recruiting |
NCT05950282 -
Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis
|
||
Completed |
NCT02248272 -
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes
|
N/A | |
Completed |
NCT00937079 -
Whole Body 111In-exendin-4 Imaging Study in Insulinoma Patients
|
Phase 1 | |
Completed |
NCT00151684 -
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
|
Phase 2 | |
Completed |
NCT00004825 -
Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
|
N/A | |
Completed |
NCT00005530 -
Diet, Insulin Resistance, and Cardiovascular Risk
|
N/A | |
Recruiting |
NCT05662189 -
Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus
|
N/A | |
Recruiting |
NCT04744896 -
Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
|
N/A | |
Completed |
NCT05329337 -
Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia
|
N/A | |
Not yet recruiting |
NCT05989347 -
Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
|
Phase 1 | |
Recruiting |
NCT05543083 -
Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05774613 -
Effect of Hibiscus Sabdariffa Beverage
|
N/A | |
Recruiting |
NCT06363929 -
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
|
||
Completed |
NCT03358745 -
Impact of Meal Order on Postprandial Cardiometabolic Risk Markers
|
N/A | |
Not yet recruiting |
NCT05764200 -
Acute Microbial Switch
|
N/A | |
Completed |
NCT00005104 -
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
|
N/A |