Endogenous Hyperinsulinaemic Hypoglycaemia
Conditions
Keywords
Localisation of Insulinoma, beta-cell imaging, exendin-4, 68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT
Brief summary
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.
Interventions
OTHERGa -exendin PET/CT, In- exendin SPECT/CT, MRI
Comparison of different imaging modalities
Sponsors
Insel Gruppe AG, University Hospital Bern
Desirée and Niels Yde's Foundation, Zürich, Switzerland
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biochemically proven endogenous hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm * Conventional imaging (CT,MRI or EUS) not older than 2 months * Signed written consent * Age above 18 years
Exclusion criteria
* Kidney failure (creatinine \> 140micromol/l) * Known allergies against Exendin-4 (Byetta or Bydureon) * Pregnancy * Breastfeeding * Medication with Byetta or Bydureon * Evidence for malignancy (extrapancreatic tumor manifestations)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring Tumour to Background Ratio | 4 years |
| Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT. | 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4 | 4 years | Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system |
| Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT | 4 years | — |
| Comparison of the angiogenesis markers with the those of breast carcinoma patients | 4 years | — |
| Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT | 4 years | — |
| Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT, 111 In-DOTA-exendin-4 SPECT/CT and standardized MRI in comparison with conventional imaging (CT,MRI and EUS) | 4 years | — |
Countries
Switzerland
Outcome results
None listed