New Imaging Procedure for the Localisation of Insulinoma

April 16, 2018 updated by: University Hospital, Basel, Switzerland
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biochemically proven endogenous hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm
  • Conventional imaging (CT,MRI or EUS) not older than 2 months
  • Signed written consent
  • Age above 18 years

Exclusion Criteria:

  • Kidney failure (creatinine > 140micromol/l)
  • Known allergies against Exendin-4 (Byetta or Bydureon)
  • Pregnancy
  • Breastfeeding
  • Medication with Byetta or Bydureon
  • Evidence for malignancy (extrapancreatic tumor manifestations)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
This is a cross-over study comparing three imaging methods (68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT, MRI) in the same patient.
Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
Comparison of different imaging modalities
Other Names:
  • MRI
  • 68Ga-DOTA-exendin-4
  • 111In-DOTA-exendin-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring Tumour to Background Ratio
Time Frame: 4 years
4 years
Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT
Time Frame: 4 years
4 years
Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT, 111 In-DOTA-exendin-4 SPECT/CT and standardized MRI in comparison with conventional imaging (CT,MRI and EUS)
Time Frame: 4 years
4 years
Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4
Time Frame: 4 years
Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system
4 years
Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT
Time Frame: 4 years
4 years
Comparison of the angiogenesis markers with the those of breast carcinoma patients
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital Inselspital, Berne
Desirée and Niels Yde's Foundation, Zürich, Switzerland

Investigators

  • Principal Investigator: Damian Wild, MD, PhD, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 6, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB 163/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endogenous Hyperinsulinaemic Hypoglycaemia

Clinical Trials on Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe