Clinical trial · Interventional
68Ga-NODAGA-exendin-4 PET/CT for Diagnostic Imaging in AHH
68Ga-NODAGA-exendin-4 PET/CT in Patients With AHH - a Prospective Comparative Evaluation of Preoperative Imaging
- 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)
In order to improve the sensitivity and specificity of pre-operative imaging localization of foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R), 68Ga-NODAGA-exendin 4. With the currently used imaging techniques, only about 70-80% of insulin producing pancreatic neuroendocrine tumors (IPPNET) can be successfully visualized. Therefore, we propose to compare GLP-1R PET imaging to the standard imaging techniques in patients scheduled for surgical removal of the tumour. These highly relevant data will allow us to interpret the benefits of GLP-1R-imaging over other imaging techniques for the diagnosis of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains challenging and frequently still leading to futile surgery or unnecessary partial pancreatectomy, a more sensitive and specific imaging technique would be of great value.
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-NODAGA-exendin 4 PET/CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NODAGA-exendin PET/CT
- description
- 68Ga-NODAGA-exendin PET/CT
- interventionNames
- Radiation: 68Ga-NODAGA-exendin 4 PET/CT
Primary outcomes (1)
- measure
- Tumor visualization by 68Ga-NODAGA-exendin-4 PET/CT and standard imaging
- timeFrame
- 1 year
Secondary outcomes (4)
- measure
- Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4
- timeFrame
- 1 year
- measure
- Retrospective surgery planning, type of surgery based on image analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biochemically proven endogenous hyperinsulinemic hypoglycemia * Signed informed consent * Standard imaging not older than 8 weeks. Exclusion Criteria: * Breast feeding * Pregnancy or the wish to become pregnant within 6 months * Calculated creatinine clearance below 40ml/min * Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions) * Age \< 18 years * No signed informed consent
References
Publications (0)
Data not yet available