New Imaging Procedure for the Localisation of Insulinoma

Not Applicable

Completed

• Conditions: Endogenous Hyperinsulinaemic Hypoglycaemia
• Interventions: Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

• Registration Number: NCT02127541
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-06
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ga -exendin PET/CT, In- exendin SPECT/CT, MRI	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.

Primary Outcome Measures

Name	Time	Method
Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.	4 years
Measuring Tumour to Background Ratio	4 years

Secondary Outcome Measures

Name	Time	Method
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
Comparison of the angiogenesis markers with the those of breast carcinoma patients	4 years
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
Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT	4 years

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland