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The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Plain-language guide to NCT04979611: phase 1 interventional trial of Exenatide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04979611
- Phase
- phase 1
- Status
- status unknown
- Start
- 2020-08-01
- Completion (planned or actual)
- 2025-08-01
- Participants
- 60 (estimated)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Insulinoma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Exenatide.
The small insulinoma can not be detected by the CT or MRI.
The researchers use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia.
And the diagnostic value will be performed.
It had 1 arm (groups): Patients will undergo 68Ga-NOTA-exendin-4 PET/CT imaging (other).
The registry classes the interventions as drug.
More on the Plan
The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R.
The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated.
And the comparation between PET diagnostic value and CT / MRI will be done.
Who Took Part
60 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: 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent.
The full record lists 1 inclusion and 1 exclusion criteria.
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 2020-08-01 with completion listed for 2025-08-01.
It ran at 1 site in China.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: Standard uptake value (SUV) (time frame: From right after tracer injection to 1-hours post-injection).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Exenatide in 60 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.