Hyperinsulinemic Hypoglycemia, Persistent[18F]-DOPANCT02533219
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
A study testing 18 F-DOPA in people with Hyperinsulinemic Hypoglycemia, Persistent and Congenital Hyperinsulinism, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Read more about this study
- Who is it for?
- Ages Up to 64 years
- Conditions the study is for
- Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
- What is being tested?
- 18 F-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 Up to 64 years
- All sexes
- Child, Adult
Who may be able to join
- All Patients clinically diagnosed with Hyperinsulinemia of any age
- Patients in need of PET scan
- Patients that require sedation
- Patients that do not require sedation
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Patients without Hyperinsulinemia
- Patients who are or may be pregnant
- Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity.
- Patient's requiring emergency surgical intervention that would be inappropriately delayed by [18F]-DOPA PET imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.
Read the detailed description
Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion and remains difficult to treat because of the requirement for extensive amounts of glucose and the lack of effective long-term medical therapy. Correct diagnosis, localization, and limited excision of the focal lesion will result in a complete cure of the patient. In contrast, medically unresponsive diffuse disease requires a near total pancreatectomy, greatly increasing the risk of future diabetes mellitus. Fortunately, [18F]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably detect and localize disease.
- Conditions
- Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
- Being tested
- 18 F-DOPA
- Keywords
- Hyperinsulinemic hypoglycemia, PET/CT, PET/MRI, [18F]-DOPA, PET/MR, Congenital Hyperinsulinism
- Medical subject headings
- Congenital Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 F-DOPADrug
Also called Fluorine-18-L-dihydroxyphenylalanine
Subjects will undergo PET imaging with [18F]-DOPA. All PET imaging will be performed after administration of a single dose (0.08 - 0.16 mCurie/kg) of [18F]-DOPA. PET imaging can be performed on either Philips Ingenuity TF PET/MRI or PET/CT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperinsulinemic Hypoglycemia, PersistentStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor J. Seghers, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533219
- Sponsor's protocol ID
- H-32432
- Acronym
- [18F]-DOPA
- Status last verified
- Sep 2020
- First submitted
- 24 Aug 2015
- Last updated
- 7 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
- ClinicalTrials.gov ID
- NCT02533219
- Acronym / sponsor ID
- [18F]-DOPA / H-32432
- Conditions
- Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
- Keywords
- Hyperinsulinemic hypoglycemia, PET/CT, PET/MRI, [18F]-DOPA, PET/MR, Congenital Hyperinsulinism
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- First posted
- 26 Aug 2015 (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.
The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.
Detailed description
Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion and remains difficult to treat because of the requirement for extensive amounts of glucose and the lack of effective long-term medical therapy. Correct diagnosis, localization, and limited excision of the focal lesion will result in a complete cure of the patient. In contrast, medically unresponsive diffuse disease requires a near total pancreatectomy, greatly increasing the risk of future diabetes mellitus. Fortunately, [18F]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably detect and localize disease.
Study design
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All Patients clinically diagnosed with Hyperinsulinemia of any age
- Patients in need of PET scan
- Patients that require sedation
- Patients that do not require sedation
Key exclusion criteria (5 listed)
- Patients without Hyperinsulinemia
- Patients who are or may be pregnant
- Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity.
- Patient's requiring emergency surgical intervention that would be inappropriately delayed by [18F]-DOPA PET imaging.
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 |
|---|---|---|
| 18 F-DOPAAlso: Fluorine-18-L-dihydroxyphenylalanineSubjects will undergo PET imaging with [18F]-DOPA. All PET imaging will be performed after administration of a single dose (0.08 - 0.16 mCurie/kg) of [18F]-DOPA. PET imaging can be performed on either Philips Ingenuity TF PET/MRI or PET/CT. | 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 7 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18 F-DOPA in people with Hyperinsulinemic Hypoglycemia, Persistent and Congenital Hyperinsulinism, run by Baylor College of Medicine 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 4 inclusion and 5 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 7 Sep 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 7 Sep 2020.