Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2018-02-07
2019-02-01
Brief Summary
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Detailed Description
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Furthermore, we will evaluate 68Ga-exendin-4 PET/CT for the pre-operative localization of foci of over-secreting beta cells in CHI and the discrimination between focal and diffuse CHI. We will compare GLP-1R PET/CT to the currently used pre-operative imaging technique (18F-DOPA PET combined with contrast enhanced CT). To compare these imaging techniques according to sensitivity, we will analyze intra-operative findings and clinical outcomes.
These highly relevant data will allow us to evaluate the expression of GLP-1R in CHI and its usefulness as a target for diagnosis of this disease. Since the localization of foci in CHI and the discrimination between focal and diffuse CHI is challenging, surgical removal of unnecessary large portions of the pancreas in frequently necessary. Evaluation of a better target for pre-operative imaging would therefore be of great value.
Objective:
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients. A 68Ga-NODAGA-exendin 4 PET/CT will be performed in all patients included in this study. The results of quantitative imaging will then be compared to GLP-1R expression and autoradiography of surgical specimens to determine the interdependency of radiotracer uptake, beta cell mass and GLP-1R expression.
Furthermore, GLP-1R imaging will be compared to the standard imaging techniques now used in pre-operative imaging of children with CHI. All patients will undergo the standard imaging procedure, consisting of an 18F-DOPA PET scan combined with a contrast-enhanced CT. The results of the GLP-1R imaging will be compared to standard imaging in respect to sensitivity for localization of the lesion and discrimination between focal and diffuse CHI. This will be determined by the comparison of the results of pre-operative imaging with intra-operative findings.
Also, the safety (side-effects) of 68Ga-NODAGA-exendin and 18F-DOPA will be assessed.
Furthermore, dosimetric calculations will be performed and the minimum radioactivity dose of 68Ga-NODAGA-exendin 4 to obtain acceptable/reliable images will be determined.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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68Ga-exendin-4 PET/CT
68Ga-exendin-4 PET/CT
Eligibility Criteria
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Inclusion Criteria
* Unresponsive to medical treatment (diazoxide)
* Indication for 18F-DOPA PET/CT based on mutation analysis
* Standard imaging (18F-DOPA PET/CT) not older than 8 weeks
* \<16 years old
* Informed consent signed by parents or legal guardians of the patient.
Exclusion Criteria
* Calculated creatinine clearance below 40 ml/min
* Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions based on CT)
* Age \> 16 years
* No signed informed consent
16 Years
ALL
No
Sponsors
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European Commission
OTHER
University College, London
OTHER
Charite University, Berlin, Germany
OTHER
University Hospital, Basel, Switzerland
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
University of Helsinki
OTHER
Turku University Hospital
OTHER_GOV
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Martin Gotthardt
Professor
Principal Investigators
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Martin Gotthardt, Prof.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Marti Boss
Role: primary
Other Identifiers
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NL54275.091.15
Identifier Type: -
Identifier Source: org_study_id