18FDOPA PET/MRI for Hyperinsulinism

(18FDOPA HI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ana Maria Arbelaez

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Washington University School of Medicine

Disqualifiers: Major illness, MRI contraindication, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you may continue your medications unless advised otherwise by your doctor.

What data supports the effectiveness of the treatment 18F-FDOPA PET/MRI Imaging for hyperinsulinism?

Research shows that 18F-FDOPA PET is useful in diagnosing congenital hyperinsulinism by accurately locating the problem areas in the pancreas, especially in infants. It has also been used to help manage neuroendocrine tumors, which are similar to the conditions being studied in this trial. ^{1 2 3 4 5}

Is 18FDOPA PET/MRI safe for humans?

The safety of 18FDOPA PET/MRI specifically isn't detailed in the provided articles, but MRI contrast agents generally have a good safety record. Gadolinium-based agents, commonly used in MRI, have been linked to a rare condition in patients with severe kidney issues, but new guidelines have minimized this risk. ^{6 7 8 9 10}

How is the 18F-FDOPA PET/MRI treatment different from other treatments for hyperinsulinism?

The 18F-FDOPA PET/MRI treatment is unique because it uses a special imaging technique to detect areas of the pancreas with abnormal insulin production, which can help in precisely locating and treating focal forms of hyperinsulinism. This approach is particularly useful for identifying specific areas that may require surgical intervention, unlike other treatments that may not provide such detailed localization. ^{1 2 3 11 12}

Research Team

Ana Maria Arbelaez

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for patients with hyperinsulinemic hypoglycemia who can't be managed safely with standard treatments and need surgery. They must have high insulin levels during low blood sugar episodes or respond to glucagon stimulation, have failed therapy with diazoxide or octreotide, and provide informed consent.

Inclusion Criteria

Subjects with signed informed consent by themselves or their parents or legal guardians

I have been diagnosed with low blood sugar due to high insulin levels.

I have tried diazoxide or octreotide for my condition without success.

Exclusion Criteria

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

Surgery is not an option for me as decided by my parents or guardians.

I can safely undergo an MRI, or if not, a PET/CT scan.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 18F-DOPA PET/MRI imaging to detect and localize focal lesions in the pancreas

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and potential surgery

4 weeks

Treatment Details

Interventions

• 18F-Fluoro Dopa PET/MRI Imaging (Radiopharmaceutical)

Trial Overview The study tests the use of a special imaging technique called 18F-Fluoro Dopa PET/MRI to find and pinpoint focal lesions in the pancreas causing hyperinsulinism before surgery at Washington University.

Participant Groups

Group I: 18F-Fluoro Dopa Imaging Experimental Treatment 1 Intervention

single arm

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington University Saint Louis, MO

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2027

Patients Recruited

2,353,000+

St. Louis Children's Hospital

Collaborator

Trials

30

Patients Recruited

83,200+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDOPA: a multiple-target molecule. Minn, H., Kauhanen, S., Seppänen, M., et al.[2016]

In a study involving six patients with hyperinsulinemic hypoglycemia, 18F-FDOPA PET imaging was only positive in one case, indicating its limited effectiveness in detecting insulinomas and beta-cell hyperplasia in adults.

The pancreatic uptake of 18F-FDOPA was not significantly different between patients with hyperinsulinemic hypoglycemia and a control group, suggesting that this imaging technique may not reliably localize insulin-secreting tumors in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited value of 18F-F-DOPA PET to localize pancreatic insulin-secreting tumors in adults with hyperinsulinemic hypoglycemia. Tessonnier, L., Sebag, F., Ghander, C., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of [¹⁸F]-fluoro-L-dihydroxyphenylalanine positron emission tomography scan for persistent congenital hyperinsulinism in Japan. Masue, M., Nishibori, H., Fukuyama, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. Kauhanen, S., Seppänen, M., Minn, H., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early 18F-FDOPA PET/CT imaging after carbidopa premedication as a valuable diagnostic option in patients with insulinoma. Leroy-Freschini, B., Amodru, V., Addeo, P., et al.[2020]

Two new molecular MRI agents have been approved for clinical use recently, and a third is in advanced clinical trials, indicating progress in the development of safer imaging options.

The review emphasizes the importance of prioritizing safety and efficacy in the design of molecular MRI agents, especially in light of past concerns like nephrogenic systemic fibrosis (NSF), which has seen no new cases reported since safety guidelines were implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular MRI of the Cardiovascular System in the Post-NSF Era. Sosnovik, DE., Caravan, P.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. Ponrartana, S., Moore, MM., Chan, SS., et al.[2021]

In a phase II clinical trial involving 104 patients, ferumoxtran-10 was found to be a safe and well-tolerated contrast agent for magnetic resonance imaging, with only 15% of patients reporting mild adverse events.

The most common side effects included dyspnea (3.8%), chest pain (2.9%), and rash (2.9%), but no serious adverse events occurred, and there were no significant changes in vital signs or laboratory results during the 48-hour observation period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data. Sharma, R., Saini, S., Ros, PR., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. Aslanian, V., Lemaignen, H., Bunouf, P., et al.[2014]

Gadolinium-based contrast agents have a strong safety record for MRI use, but a serious condition called nephrogenic systemic fibrosis was linked to their use in patients with severe kidney issues, leading to significant changes in medical practices since 2009.

Following the identification of nephrogenic systemic fibrosis, new guidelines were implemented that have nearly eliminated the occurrence of this disease, highlighting the importance of monitoring and adjusting medical practices based on emerging safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Gadolinium-Based Contrast Agents: Changes in Practice Patterns. Forghani, R.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasting 18F-DOPA PET uptake after clinical remission of the focal form of congenital hyperinsulinism. Yorifuji, T., Hosokawa, Y., Fujimaru, R., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 DOPA-PET and PET/CT Imaging in Congenital Hyperinsulinism. Houseni, M., Chamroonrat, W., Zhuang, H., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-FDOPA: a multiple-target molecule. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Limited value of 18F-F-DOPA PET to localize pancreatic insulin-secreting tumors in adults with hyperinsulinemic hypoglycemia. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of [¹⁸F]-fluoro-L-dihydroxyphenylalanine positron emission tomography scan for persistent congenital hyperinsulinism in Japan. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Early 18F-FDOPA PET/CT imaging after carbidopa premedication as a valuable diagnostic option in patients with insulinoma. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Molecular MRI of the Cardiovascular System in the Post-NSF Era. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse Effects of Gadolinium-Based Contrast Agents: Changes in Practice Patterns. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Lasting 18F-DOPA PET uptake after clinical remission of the focal form of congenital hyperinsulinism. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Fluorine-18 DOPA-PET and PET/CT Imaging in Congenital Hyperinsulinism. [2016]