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New Imaging Procedure for the Localisation of Insulinoma

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ClinicalTrials.gov Identifier: NCT02127541
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Endogenous Hyperinsulinaemic Hypoglycaemia Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

Study Design

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 2014
Primary Completion Date : November 2017
Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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-4SPECT/CT [ Time Frame: 4 years ]
  5. Comparison of the angiogenesis markers with the those of breast carcinoma patients [ Time Frame: 4 years ]

Eligibility Criteria

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

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)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02127541


Locations
Switzerland
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
Investigators
Principal Investigator: Damian Wild, MD, PhD University Hospital, Basel, Switzerland
More Information

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02127541     History of Changes
Other Study ID Numbers: EKBB 163/12
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Keywords provided by University Hospital, Basel, Switzerland:
Localisation of Insulinoma
beta-cell imaging
exendin-4
68Ga-DOTA-exendin-4 PET/CT
111In-DOTA-exendin-4 SPECT/CT

Additional relevant MeSH terms:
Insulinoma
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Adenoma, Islet Cell
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists