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68Ga-NODAGA-exendin-4 PET/CT for Diagnostic Imaging in AHH

NCT03189953 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-06-16

No results posted yet for this study

Summary

In order to improve the sensitivity and specificity of pre-operative imaging localization of foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R), 68Ga-NODAGA-exendin 4. With the currently used imaging techniques, only about 70-80% of insulin producing pancreatic neuroendocrine tumors (IPPNET) can be successfully visualized. Therefore, we propose to compare GLP-1R PET imaging to the standard imaging techniques in patients scheduled for surgical removal of the tumour. These highly relevant data will allow us to interpret the benefits of GLP-1R-imaging over other imaging techniques for the diagnosis of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains challenging and frequently still leading to futile surgery or unnecessary partial pancreatectomy, a more sensitive and specific imaging technique would be of great value.

Conditions

  • Insulinoma

Interventions

RADIATION

68Ga-NODAGA-exendin 4 PET/CT

68Ga-NODAGA-exendin 4 PET/CT

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • University of Turku

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Martin Gotthardt, Prof. Dr. · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-01-31
Completion
2021-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189953 on ClinicalTrials.gov