New Imaging Procedure for the Localisation of Insulinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-06

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Endogenous Hyperinsulinaemic Hypoglycaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

Intervention Type OTHER

Comparison of different imaging modalities

Interventions

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Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

Comparison of different imaging modalities

Intervention Type OTHER

Other Intervention Names

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68Ga-DOTA-exendin-4 111In-DOTA-exendin-4 MRI

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No