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New Imaging Procedure for the Localisation of Insulinoma and Transplanted Islet Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Desirée and Niels Yde's Foundation, Zürich, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02127541
First received: February 10, 2014
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.

Beta cell mass (BCM): The in vivo determination of BCM is currently impossible due to the lack of a reliable tool. Quantitative assessment of BCM in vivo is of enormous interest for patients with type 1 (T1D) and type 2 diabetes mellitus (T2D) in order to evaluate pathophysiological mechanisms of T1D and T2D and potential therapeutical interventions aiming at the prevention of autoimmune beta cell destruction (i.e. in T1D before clinical diagnosis or after islets transplantation) or preservation of BCM in T2D. Radionuclide-based methodology (GLP-1R imaging using) radioligands that directly target beta cells appears particularly promising.


Condition Intervention Phase
Endogenous Hyperinsulinaemic Hypoglycaemia
Transplanted Islet Cells
Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: New Imaging Procedure for the Localisation of Insulinoma and Transplanted Islet Cells

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Measuring Tumour to Background Ratio and the Sensitivity of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    By means of measuring the standard uptake value of tumour manifestations and the surrounding tissue in PET/CT and SPECT/CT tumour localisations can be determined and used to aid and confirm visual detection.


Secondary Outcome Measures:
  • Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT in comparison with conventional imaging (CT,MRI and EUS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Dosimetry Calculation of 68Ga-DOTA-Exendin 4 and 111 In-DOTA-Exendin-4 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Dosimetry Calculation allows the calculation of the effective radiation dose of each method.

  • Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system

  • Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4SPECT/CT [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Correlation between number of transplanted islet cells and the standard uptake value in PET or tumour to background ration in PET and SPECT [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Comparison of the angiogenesis markers with the those of breast carcinoma patients [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: January 2014
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127541

Contacts
Contact: Damian Wild, MD, PhD 0613286683 damian.wild@usb.ch
Contact: Emanuel Christ, MD, PhD Emanuel.Christ@insel.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Damian Wild, MD, PhD    0613286683    damian.wild@usb.ch   
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
Study First Received: February 10, 2014
Last Updated: October 27, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health
Switzerland: Swissmedic

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
Adenoma
Adenoma, Islet Cell
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Pancreatic Neoplasms
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014