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New treatment option for Congenital Hyperinsulinism
Official title Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
ClinicalTrials.gov ID: NCT02021604
What this study is testing
What is Fluorodopa F 18?
Fluorodopa F 18 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for congenital hyperinsulinism.
Also referred to as Fluorodopa 18F (International Non-Proprietary Name), 6-[18F]fluorolevodopa (U.S. Pharmacopeia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Patients with HI attending the Cook Children's Congenital Hyperinsulinism Center and being treated by an Endocrinologist which may be the PI or a...
- The patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is...
- Hypoglycemia (blood glucose \<70 m/dL) on a single measure despite the use of anti-hypoglycemic medications, if applicable to the individual patient...
- 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...
- Patients in whom the genetic testing (if available and informative) does not prove diffuse HI disease. Such children might be considered if they have...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.