Using Fluorodopa F 18 to locate insulin-producing tumors in patients with congenital hyperinsulinism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A new PET/CT test to find insulinoma using a GLP-1R tracer compared to an earlier tracer

  A GLP-1 receptor–targeted PET/CT imaging agent is being tested in adults with suspected or confirmed insulinoma to see if the PEG6-modified tracer locates tumors better than the original tracer.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07808879

• EUS-guided radiofrequency ablation for pancreatic insulinoma safety and effectiveness

  This project will try EUS-guided radiofrequency ablation (EUS-RFA) to treat people with pathology-confirmed pancreatic insulinoma and compare safety and outcomes to historic surgical patients.

  Recruiting Sahlgrenska University Hospital · Gothenburg · NCT07585032

• Endoscopic ultrasound-guided radiofrequency ablation for pancreatic and left adrenal lesions

  This will try EUS-guided radiofrequency ablation to control symptoms and hormone-related problems in adults with small pancreatic neuroendocrine tumors (including insulinomas) or certain left adrenal adenomas.

  Recruiting Herlev Hospital · Herlev, Capital Region · NCT07272187

• Using PET/CT imaging to diagnose GLP-1 receptor related diseases

  This study is testing a special imaging scan to see if it can help doctors better diagnose cancer in adults who may have diseases related to GLP-1 receptors.

  Recruiting at 3 sites Tianjin Medical University · Hefei, Anhui and 2 other locations · NCT06725693

• Optimizing PET Imaging with 18F-DOPA for Various Conditions

  This study is testing if a special imaging technique using 18F-DOPA can help doctors see and understand conditions like congenital hyperinsulinism, neuroblastoma, neuroendocrine tumors, Parkinson's disease, and Lewy body dementia better in both kids and adults.

  Recruiting Phase 3 University of Alberta · Edmonton, Alberta · NCT04706910

• Using 18F-FluoroLDOPA PET imaging to find focal congenital hyperinsulinism

  This study is testing if a special type of PET imaging can help doctors find specific areas in the pancreas of infants with congenital hyperinsulinism that can be surgically removed to improve their condition.

  Recruiting Phase 2 University of California, San Francisco · San Francisco, California · NCT04205604

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.