Whole Body 111In-exendin-4 Imaging Study in Insulinoma Patients
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hyperinsulinism Hypoglycemia Insulinoma |
Other: 111In-exendin-4 imaging |
Phase 1 |
| Study Type: | Observational |
| Study Design: | 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 |
- Detection of insulinomas, cure rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Tumor tissue
| Estimated Enrollment: | 6 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
-
Other: 111In-exendin-4 imaging
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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®)
Contacts and Locations| Contact: Damian Wild, MD | damian.wild@uniklinik-freiburg.de |
| Switzerland | |
| University Hospital Basel, Institute of Nuclear Medicine | Recruiting |
| Basel, Switzerland, CH-4031 | |
| Contact: Flavio Forrer, MD, PhD ForrerF@uhbs.ch | |
| Sub-Investigator: Flavio Forrer, MD, PhD | |
| Principal Investigator: | Damian Wild, MD | University Hospital, Basel, Switzerland |
More Information
Publications:
| Responsible Party: | Jan Mueller-Brand, MD, Head of the Institute of Nuclear Medicine, University Hospital Basel |
| ClinicalTrials.gov Identifier: | NCT00937079 History of Changes |
| Other Study ID Numbers: | OCS-01778-1 |
| Study First Received: | July 2, 2009 |
| Last Updated: | June 29, 2010 |
| Health Authority: | Switzerland: Federal Office of Public Health Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
Glucagon-like peptide-1 receptor targeting Insulinoma imaging Exendin-4 molecular imaging |
Additional relevant MeSH terms:
|
Hyperinsulinism Hypoglycemia Insulinoma Glucose Metabolism Disorders Metabolic Diseases Adenoma, Islet Cell Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms |
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Glucagon Glucagon-Like Peptide 1 Exenatide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Incretins Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 23, 2013