New Imaging Procedure for the Localisation of Insulinoma

Study Overview
=================
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.

Official Title
-----------------
New Imaging Procedure for the Localisation of Insulinoma

Conditions
-----------------
Endogenous Hyperinsulinaemic Hypoglycaemia

Intervention / Treatment
-----------------
* Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI<br>This is a cross-over study comparing three imaging methods (68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT, MRI) in the same patient. | Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI<br>* Comparison of different imaging modalities<br>* Other names: MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4 | Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system | 4 years | 
| Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT |  | 4 years | 
| Comparison of the angiogenesis markers with the those of breast carcinoma patients |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Localisation of Insulinoma, beta-cell imaging, exendin-4, 68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT