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The Physiology of Glucagon-like-peptide-1 Receptor Expression in Patients With Endogenous Hyperinsulinism - Correlation With Histopathology

Phase 1
18 Years
90 Years
Open (Enrolling)
Hyperinsulinism, Hypoglycemia, Insulinoma

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Trial Information

The Physiology of Glucagon-like-peptide-1 Receptor Expression in Patients With Endogenous Hyperinsulinism - Correlation With Histopathology

Insulinomas arise from pancreatic cells and are the most frequent hormone-active tumours of
the pancreas. Insulinomas produce insulin and can become life threatening if they cannot be
localised and removed surgically. Complete tumour resection cures most patients, hence
surgery is the treatment of choice for begin and malignant insulinomas. The potential for
surgical cure necessitates accurate tumour localisation before surgery because preoperative
imaging facilitates the detection of small localised, multiple and metastatic insulinomas.
However, the successful localisation of insulinomas is an challenging problem since
approximately 30% of insulinomas cannot be visualised radiographically.

A novel nuclear medicine scanning method using radioactive exendin-4 (111In-exendin-4) has
recently been developed for imaging of insulinomas. 111In-exendin-4 accumulates specifically
in insulinoma cells via the glucagon-like peptide-1 (GLP-1) receptor. The accumulation of
111In-exendin-4 can be visualised by the use of a special camera (Single Photon Emission
Computed Tomography (SPECT) camera) that detects radioactivity and lights up tumours as hot

The decision to perform surgery is independent of this study. If surgery is performed a
small sample of the tumor will be used for identifying the sites where 111In-exendin-4 binds
to the tumor.

Inclusion Criteria:

- Biochemically proven endogenous hyperinsulinism confirmed by hypoglycaemia with
neuroglycopenic symptoms, inadequately high serum insulin and C-peptide
concentrations and negative sulfonylurea screening as well as low serum
beta-hydroxybutyrate concentrations

- Able and willing to provide written informed consent

Exclusion Criteria:

- Renal insufficiency (creatinine > 140 micromol/l)

- Pregnancy or positive pregnancy test which will be performed in all patients without
contraception and aged < 50 years

- Allergy to exendin-4 (Byetta®)

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Detection of insulinomas, cure rate

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Damian Wild, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Basel, Switzerland


Switzerland: Federal Office of Public Health

Study ID:




Start Date:

November 2007

Completion Date:

November 2010

Related Keywords:

  • Hyperinsulinism
  • Hypoglycemia
  • Insulinoma
  • Glucagon-like peptide-1 receptor targeting
  • Insulinoma imaging
  • Exendin-4
  • molecular imaging
  • Hyperinsulinism
  • Hypoglycemia
  • Insulinoma