Clinical trial · Interventional
Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
NCT04185350CI-TRIAL-00042058unknownEarly 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)
Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor. The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-MAL-Cys39-exendin-4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT
- description
- The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later.
- interventionNames
- Drug: 68Ga-NOTA-MAL-Cys39-exendin-4
Primary outcomes (1)
- measure
- Standardized uptake value
- timeFrame
- 1 year
- description
- Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma
Secondary outcomes (2)
- measure
- GLP-1 receptor expression by histology compared to tracer uptake
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient volunteers and signs an informed consent form. 2. age ≥18 and ≤75 years old; 3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad; 4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml); 5. Conventional imaging within 3 month. Exclusion Criteria: 1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases; 2. Breast feeding; 3. Pregnancy or the wish to become pregnant within 6 months; 4. Renal function: serum creatinine \> 3.0 mg/dl; 5. 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.