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Trial record 3 of 43 for:    "Insulinoma"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00937079
First received: July 2, 2009
Last updated: June 29, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

residents of Switzerland

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937079

Contacts
Contact: Damian Wild, MD damian.wild@uniklinik-freiburg.de

Locations
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         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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:
Insulinoma
Hyperinsulinism
Hypoglycemia
Adenoma
Adenoma, Islet Cell
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Pancreatic Neoplasms
Exenatide
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014