Whole Body 111In-exendin-4 Imaging Study in Insulinoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00937079
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):
Damian Wild, University Hospital, Basel, Switzerland

Brief Summary:
The purpose of this study is to determine whether the investigators' new imaging modality (111In-exendin-4) has advantages in detecting insulinomas in comparison to conventional imaging.

Condition or disease Intervention/treatment
Hyperinsulinism Hypoglycemia Insulinoma Other: 111In-exendin-4 imaging

Detailed Description:

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 spots.

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.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Physiology of Glucagon-like-peptide-1 Receptor Expression in Patients With Endogenous Hyperinsulinism - Correlation With Histopathology
Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Intervention Details:
  • Other: 111In-exendin-4 imaging
    90-100 megabecquerel (MBq) (30 microgram or less) 111In-exendin-4 IV once

Primary Outcome Measures :
  1. Detection of insulinomas, cure rate [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
Tumor tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
residents of Switzerland

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®)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00937079

University Hospital Basel, Institute of Nuclear Medicine
Basel, Basel-Stadt, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Damian Wild, MD University Hospital, Basel, Switzerland

Publications of Results:
Responsible Party: Damian Wild, MD, University Hospital, Basel, Switzerland Identifier: NCT00937079     History of Changes
Other Study ID Numbers: OCS-01778-1
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Damian Wild, University Hospital, Basel, Switzerland:
Glucagon-like peptide-1 receptor targeting
Insulinoma imaging
molecular imaging

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents