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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00937079
Enrollment
30
Registered
2009-07-10
Start date
2007-11-30
Completion date
2011-12-31
Last updated
2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperinsulinism, Hypoglycemia, Insulinoma

Keywords

Glucagon-like peptide-1 receptor targeting, Insulinoma imaging, Exendin-4, molecular imaging

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.

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.

Interventions

OTHER111In-exendin-4 imaging

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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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®)

Design outcomes

Primary

MeasureTime frame
Detection of insulinomas, cure rateone year

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026