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New Imaging Procedure for the Localisation of Insulinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02127541
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : April 18, 2018
University Hospital Inselspital, Berne
Desirée and Niels Yde's Foundation, Zürich, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endogenous Hyperinsulinaemic Hypoglycaemia Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: New Imaging Procedure for the Localisation of Insulinoma
Study Start Date : January 6, 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

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:
  • 68Ga-DOTA-exendin-4
  • 111In-DOTA-exendin-4
  • MRI

Primary Outcome Measures :
  1. Measuring Tumour to Background Ratio [ Time Frame: 4 years ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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. Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT [ Time Frame: 4 years ]
  5. Comparison of the angiogenesis markers with the those of breast carcinoma patients [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02127541

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University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
Desirée and Niels Yde's Foundation, Zürich, Switzerland
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Principal Investigator: Damian Wild, MD, PhD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT02127541     History of Changes
Other Study ID Numbers: EKBB 163/12
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by University Hospital, Basel, Switzerland:
Localisation of Insulinoma
beta-cell imaging
68Ga-DOTA-exendin-4 PET/CT
111In-DOTA-exendin-4 SPECT/CT
Additional relevant MeSH terms:
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Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Infant, Newborn, Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists