Clinical trial · Interventional
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
NCT02560376CI-TRIAL-00019209unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulinoma | Pancreatic Insulinoma | ALIAS | 0.90 |
| Nesidioblastosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-exendin-4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-exendin-4 PET/CT
- description
- The patients were injected with 55.5-111 MBq of 68Ga-NOTA-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 30-60 min later.
- interventionNames
- Drug: 68Ga-NOTA-exendin-4
Primary outcomes (1)
- measure
- Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Adverse events collection
- timeFrame
- 1 week
- description
- Adverse events within 1 week after the injection and scanning of patients will be followed and assessed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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). * Conventional imaging within 1 month * Signed written consent * Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study) Exclusion Criteria: * Pregnancy * Breastfeeding * Renal function: serum creatinine \> 3.0 mg/dl * Known allergy against exendin-4 * Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.