Using Fluorodopa F 18 to locate insulin-producing tumors in patients with congenital hyperinsulinism
The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma
This study tests whether a special imaging technique using Fluorodopa F 18 can help find insulin-producing tumors in patients with congenital hyperinsulinism to improve their treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Cook Children's Health Care System Academic / other |
| Locations | 1 site (Fort Worth, Texas) |
| Trial ID | NCT02021604 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Fluorodopa F 18 in conjunction with PET scans to identify focal lesions in patients with congenital hyperinsulinism and insulinoma. These conditions lead to excessive insulin production, causing severe hypoglycemia and potential brain damage. By accurately locating the source of insulin overproduction, surgeons can perform targeted resections to cure the condition. The study aims to improve patient outcomes by reducing the risks associated with traditional invasive diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates include infants and children diagnosed with congenital hyperinsulinism who have not responded to standard medical therapies and require surgical intervention.
Not a fit: Patients with diffuse congenital hyperinsulinism or those who have not failed medical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of brain damage in infants with congenital hyperinsulinism by enabling precise surgical intervention.
How similar studies have performed: Previous studies have shown promising results using similar imaging techniques for neuroendocrine tumors, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with HI attending the Cook Children's Congenital Hyperinsulinism Center and being treated by an Endocrinologist which may be the PI or a partner of this clinician. * The 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. Failure of medical therapy is defined as both: * Hypoglycemia (blood glucose \<70 m/dL) on a single measure despite the use of anti-hypoglycemic medications, if applicable to the individual patient, including and limited to diazoxide or octreotide * Inability to fast, defined as the inability to maintain a blood glucose \>50 mg/dL for: 1) more than 12 hours for infants \< 1 year of age; 2) more than 15 hours 1-3 years of age; 3) more than 18 hours over 3 years of age * Patients in whom the genetic testing (if available and informative) does not prove diffuse HI disease. Such children might be considered if they have one or more of the following situations: * no genetic testing results (e.g., due to insurance denial or parental refusal) * negative genetic testing (note: only 75% of mutations may be found with existing technology) * no autosomal recessive mutations in ABCC8 or KCNJ11 on the maternal allele * no autosomal dominant mutations in ABCC8 or KCNJ11 * Patients thought to have focal HI disease based on genetic testing or insulinoma based on clinical evaluation and have well-controlled blood glucose levels with any degree of dietary or medical management, BUT the patient and their parent(s) or LAR wishes to proceed with surgery for a possible cure of HI disease. Exclusion Criteria: * Patients who do not have a diagnosis of HI * Patients with genetic evidence of diffuse HI * Patients who are pregnant * Nursing mothers who are unwilling to discontinue breastfeeding their infant for 48 hours after Fluorodopa F 18 injection * Patients with a known allergy to Fluorodopa F 18 agent
Where this trial is running
Fort Worth, Texas
- Cook Children's Medical Center — Fort Worth, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Paul Thornton, MD — Cook Children's Health Care System
- Study coordinator: Deborah Rafferty, PhD
- Email: Deborah.Rafferty@cookchildrens.org
- Phone: 682-303-1363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.