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

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937079
• Other study ID #: OCS-01778-1
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2009
• Last updated: January 8, 2015
• Start date: November 2007
• Est. completion date: December 2011

Study information

• Verified date: January 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public HealthSwitzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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®)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperinsulinism
• Hypoglycemia
• Insulinoma

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Institute of Nuclear Medicine	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Christ E, Wild D, Forrer F, Brändle M, Sahli R, Clerici T, Gloor B, Martius F, Maecke H, Reubi JC. Glucagon-like peptide-1 receptor imaging for localization of insulinomas. J Clin Endocrinol Metab. 2009 Nov;94(11):4398-405. doi: 10.1210/jc.2009-1082. Epub — View Citation

Wild D, Mäcke H, Christ E, Gloor B, Reubi JC. Glucagon-like peptide 1-receptor scans to localize occult insulinomas. N Engl J Med. 2008 Aug 14;359(7):766-8. doi: 10.1056/NEJMc0802045. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of insulinomas, cure rate		one year	Yes