← Human Trials & Peer-Reviewed Studies
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
Plain-language guide to NCT02560376: early phase 1 interventional trial of Exenatide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02560376
- Phase
- early phase 1
- Status
- status unknown
- Start
- 2014-02
- Completion (planned or actual)
- 2016-12
- Participants
- 100 (estimated)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Insulinoma; Nesidioblastosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test Exenatide.
Visual and semiquantitative method will be used to assess the PET/CT images.
It had 1 arm (groups): 68Ga-NOTA-exendin-4 PET/CT (experimental).
The registry classes the interventions as drug.
More on the Plan
68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R.
The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.
Who Took Part
The registry lists 100 planned participants were the target.
It was open to people of any sex aged from 6 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml). Signed written consent. Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study).
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: known allergy against exendin-4.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Exenatide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-02 with completion listed for 2016-12.
It ran at 1 site in China.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis (time frame: 1 year).
It also tracked 1 secondary outcome, for example Adverse events collection.
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Exenatide in 100 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.