Congenital Hyperinsulinism (CHI)NCT01916148
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
A study testing 18F-DOPA in people with Congenital Hyperinsulinism (CHI) and Beckwith-Wiedemann Syndrome, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Hyperinsulinism (CHI), Beckwith-Wiedemann Syndrome, Insulinoma
- What is being tested?
- 18F-DOPA
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation.
- Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery
Who cannot join
- Pregnant or lactating females
- 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
- Subjects who are not a candidate for pancreatic surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Lisa States, MD
About this study
Official title: Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.
Read the detailed description
Patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. Early surgical intervention can be preventative. F-DOPA PET may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.
- Being tested
- 18F-DOPA
- Keywords
- Hypoglycemia, Hyperinsulinism (HI), F-DOPA, PET, 18-F DOPA, 18F-L-Fluoro-DOPA, 18F-fluoro-L-dihydroxyphenylalanine, focal pancreatic lesions, congenital hyperinsulinism, Beckwith Wiedemann Syndrome, insulinoma, Hyperinsulinemic Hypoglycemia, F-DOPA PET, CHI (Congenital hyperinsulinism)
- Medical subject headings
- Congenital Hyperinsulinism, Beckwith-Wiedemann Syndrome, Insulinoma, Hypoglycemia, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DOPADrug
Also called 18F-fluoro-L-dihydroxyphenylalanine, 18F-L-Fluoro-DOPA
18F-DOPA is a PET (Positron Emission Tomography) scan radiotracer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Congenital Hyperinsulinism (CHI)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa States, Children's Hospital of Philadelphia
- Investigators
- Lisa States, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916148
- Sponsor's protocol ID
- 12-009528
- Status last verified
- Apr 2026
- First submitted
- 30 Jul 2013
- Last updated
- 27 Apr 2026
- Results posted
- No
Publications
https://jnm.snmjournals.org/content/63/supplement_2/2388 Abstract 2388 Authors: Nithya Navarathna, Deepa Dalal, Susan Becker and Lisa States Title: 18F-FDOPA PET imaging in Congenital Hyperinsulinism for localization of a Focal Pancreatic Lesion: Do medications interfere with radiotracer uptake? Journal of Nuclear Medicine Vol. 63, Issue supplement 2 August 1, 2022
https://jnm.snmjournals.org/content/65/supplement_2/242379 Abstract 242379 Authors Eva Hamel, Lisa States and Susan Becker Title:18F-FDOPA PET/CT Imaging for Congenital Hyperinsulinism: What is the optimal imaging time? Journal of Nuclear Medicine Vol. 65, Issue supplement 2 June 1, 2024
States LJ, Becker SA, De Leon DD. Congenital hyperinsulinism: localization of a focal lesion with 18F-FDOPA positron emission tomography. Pediatr Radiol. 2022 Apr;52(4):693-701. doi: 10.1007/s00247-021-05206-5. Epub 2021 Oct 19.
PubMed 34668049Sanders VR, Lord K, Sigal W, McKnight H, Wilkinson E, Mitteer LM, Boodhansingh KE, Adzick NS, States LJ, Bhatti TR, De Leon DD. Double Trouble: When Focal and Diffuse Hyperinsulinism Occur Simultaneously. Horm Res Paediatr. 2026 Mar 8:1-10. doi: 10.1159/000550909. Online ahead of print.
PubMed 41795819States LJ, Francis P, Hamel ER, Becker SA, De Leon DD. Evaluation of Congenital Hyperinsulinism Using 18F-FDOPA PET. PET Clin. 2026 Apr;21(2):321-330. doi: 10.1016/j.cpet.2025.11.001. Epub 2026 Jan 14.
PubMed 41539914Boodhansingh KE, Yang Z, Li C, Chen P, Lord K, Becker SA, States LJ, Adzick NS, Bhatti T, Shyng SL, Ganguly A, Stanley CA, De Leon DD. Localized islet nuclear enlargement hyperinsulinism (LINE-HI) due to ABCC8 and GCK mosaic mutations. Eur J Endocrinol. 2022 Jun 27;187(2):301-313. doi: 10.1530/EJE-21-1095. Print 2022 Aug 1.
PubMed 35674212Rosenfeld E, Mitteer L, Boodhansingh K, Becker SA, McKnight H, Boyajian L, Ackermann AM, Kalish JM, Bhatti TR, States LJ, Adzick NS, Lord K, De Leon DD. Case Report: Two Distinct Focal Congenital Hyperinsulinism Lesions Resulting From Separate Genetic Events. Front Pediatr. 2021 Jul 16;9:699129. doi: 10.3389/fped.2021.699129. eCollection 2021.
PubMed 34336745Adzick NS, De Leon DD, States LJ, Lord K, Bhatti TR, Becker SA, Stanley CA. Surgical treatment of congenital hyperinsulinism: Results from 500 pancreatectomies in neonates and children. J Pediatr Surg. 2019 Jan;54(1):27-32. doi: 10.1016/j.jpedsurg.2018.10.030. Epub 2018 Oct 5.
PubMed 30343978States LJ, Davis JC, Hamel SM, Becker SA, Zhuang H. 18F-6-Fluoro-l-Dopa PET/CT Imaging of Congenital Hyperinsulinism. J Nucl Med. 2021 Jul;62(Suppl 2):51S-56S. doi: 10.2967/jnumed.120.246033.
PubMed 34230074States LJ, Saade-Lemus S, De Leon DD. 18-F-L 3,4-Dihydroxyphenylalanine PET/Computed Tomography in the Management of Congenital Hyperinsulinism. PET Clin. 2020 Jul;15(3):349-359. doi: 10.1016/j.cpet.2020.03.004.
PubMed 32498990
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
- ClinicalTrials.gov ID
- NCT01916148
- Acronym / sponsor ID
- 12-009528
- Keywords
- Hypoglycemia, Hyperinsulinism (HI), F-DOPA, PET, 18-F DOPA, 18F-L-Fluoro-DOPA, 18F-fluoro-L-dihydroxyphenylalanine, focal pancreatic lesions
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.
Detailed description
Patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. Early surgical intervention can be preventative. F-DOPA PET may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation.
- Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery
Key exclusion criteria (3 listed)
- Pregnant or lactating females
- 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
- Subjects who are not a candidate for pancreatic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DOPAAlso: 18F-fluoro-L-dihydroxyphenylalanine, 18F-L-Fluoro-DOPA18F-DOPA is a PET (Positron Emission Tomography) scan radiotracer. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Backgroundhttps://jnm.snmjournals.org/content/63/supplement_2/2388 Abstract 2388 Authors: Nithya Navarathna, Deepa Dalal, Susan Becker and Lisa States Title: 18F-FDOPA PET imaging in Congenital Hyperinsulinism for localization of a Focal Pancreatic Lesion: Do medications interfere with radiotracer uptake? Journal of Nuclear Medicine Vol. 63, Issue supplement 2 August 1, 2022
- Backgroundhttps://jnm.snmjournals.org/content/65/supplement_2/242379 Abstract 242379 Authors Eva Hamel, Lisa States and Susan Becker Title:18F-FDOPA PET/CT Imaging for Congenital Hyperinsulinism: What is the optimal imaging time? Journal of Nuclear Medicine Vol. 65, Issue supplement 2 June 1, 2024
- Background: PubMed 34668049States LJ, Becker SA, De Leon DD. Congenital hyperinsulinism: localization of a focal lesion with 18F-FDOPA positron emission tomography. Pediatr Radiol. 2022 Apr;52(4):693-701. doi: 10.1007/s00247-021-05206-5. Epub 2021 Oct 19.
- Background: PubMed 41795819Sanders VR, Lord K, Sigal W, McKnight H, Wilkinson E, Mitteer LM, Boodhansingh KE, Adzick NS, States LJ, Bhatti TR, De Leon DD. Double Trouble: When Focal and Diffuse Hyperinsulinism Occur Simultaneously. Horm Res Paediatr. 2026 Mar 8:1-10. doi: 10.1159/000550909. Online ahead of print.
- Background: PubMed 41539914States LJ, Francis P, Hamel ER, Becker SA, De Leon DD. Evaluation of Congenital Hyperinsulinism Using 18F-FDOPA PET. PET Clin. 2026 Apr;21(2):321-330. doi: 10.1016/j.cpet.2025.11.001. Epub 2026 Jan 14.
- Background: PubMed 35674212Boodhansingh KE, Yang Z, Li C, Chen P, Lord K, Becker SA, States LJ, Adzick NS, Bhatti T, Shyng SL, Ganguly A, Stanley CA, De Leon DD. Localized islet nuclear enlargement hyperinsulinism (LINE-HI) due to ABCC8 and GCK mosaic mutations. Eur J Endocrinol. 2022 Jun 27;187(2):301-313. doi: 10.1530/EJE-21-1095. Print 2022 Aug 1.
- Background: PubMed 34336745Rosenfeld E, Mitteer L, Boodhansingh K, Becker SA, McKnight H, Boyajian L, Ackermann AM, Kalish JM, Bhatti TR, States LJ, Adzick NS, Lord K, De Leon DD. Case Report: Two Distinct Focal Congenital Hyperinsulinism Lesions Resulting From Separate Genetic Events. Front Pediatr. 2021 Jul 16;9:699129. doi: 10.3389/fped.2021.699129. eCollection 2021.
- Background: PubMed 30343978Adzick NS, De Leon DD, States LJ, Lord K, Bhatti TR, Becker SA, Stanley CA. Surgical treatment of congenital hyperinsulinism: Results from 500 pancreatectomies in neonates and children. J Pediatr Surg. 2019 Jan;54(1):27-32. doi: 10.1016/j.jpedsurg.2018.10.030. Epub 2018 Oct 5.
- Background: PubMed 34230074States LJ, Davis JC, Hamel SM, Becker SA, Zhuang H. 18F-6-Fluoro-l-Dopa PET/CT Imaging of Congenital Hyperinsulinism. J Nucl Med. 2021 Jul;62(Suppl 2):51S-56S. doi: 10.2967/jnumed.120.246033.
- Background: PubMed 32498990States LJ, Saade-Lemus S, De Leon DD. 18-F-L 3,4-Dihydroxyphenylalanine PET/Computed Tomography in the Management of Congenital Hyperinsulinism. PET Clin. 2020 Jul;15(3):349-359. doi: 10.1016/j.cpet.2020.03.004.
- Study description on CHOP research websiteLink provided by the sponsor.
- CHOP HI Center program webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa States, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DOPA in people with Congenital Hyperinsulinism (CHI) and Beckwith-Wiedemann Syndrome, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Becker, RN, BSN, CCRC (267-426-0269, Beckers@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916148, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.