New Imaging Procedure for the Localisation of Insulinoma and Transplanted Islet Cells
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.
Beta cell mass (BCM): The in vivo determination of BCM is currently impossible due to the lack of a reliable tool. Quantitative assessment of BCM in vivo is of enormous interest for patients with type 1 (T1D) and type 2 diabetes mellitus (T2D) in order to evaluate pathophysiological mechanisms of T1D and T2D and potential therapeutical interventions aiming at the prevention of autoimmune beta cell destruction (i.e. in T1D before clinical diagnosis or after islets transplantation) or preservation of BCM in T2D. Radionuclide-based methodology (GLP-1R imaging using) radioligands that directly target beta cells appears particularly promising.
|Endogenous Hyperinsulinaemic Hypoglycaemia Transplanted Islet Cells||Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||New Imaging Procedure for the Localisation of Insulinoma and Transplanted Islet Cells|
- Measuring Tumour to Background Ratio and the Sensitivity of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT [ Time Frame: 6 months ]By means of measuring the standard uptake value of tumour manifestations and the surrounding tissue in PET/CT and SPECT/CT tumour localisations can be determined and used to aid and confirm visual detection.
- Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT in comparison with conventional imaging (CT,MRI and EUS) [ Time Frame: 6 months ]
- Dosimetry Calculation of 68Ga-DOTA-Exendin 4 and 111 In-DOTA-Exendin-4 [ Time Frame: 12 months ]Dosimetry Calculation allows the calculation of the effective radiation dose of each method.
- Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4 [ Time Frame: 1 month ]Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system
- Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4SPECT/CT [ Time Frame: 4 years ]
- Correlation between number of transplanted islet cells and the standard uptake value in PET or tumour to background ration in PET and SPECT [ Time Frame: 4 years ]
- Comparison of the angiogenesis markers with the those of breast carcinoma patients [ Time Frame: 4 years ]
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
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
Comparison of different imaging modalities
Please refer to this study by its ClinicalTrials.gov identifier: NCT02127541
|Contact: Damian Wild, MD, PhDemail@example.com|
|Contact: Emanuel Christ, MD, PhD||Emanuel.Christ@insel.ch|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4031|
|Contact: Damian Wild, MD, PhD 0613286683 firstname.lastname@example.org|
|Principal Investigator:||Damian Wild, MD, PhD||University Hospital, Basel, Switzerland|