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New Imaging Procedure for the Localisation of Insulinoma

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University Hospital Basel

Status

Completed

Conditions

Endogenous Hyperinsulinaemic Hypoglycaemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02127541
EKBB 163/12

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

52 participants in 1 patient group

Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
Experimental group
Description:
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.
Treatment:
Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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