search
Back to results

New Imaging Procedure for the Localisation of Insulinoma

Primary Purpose

Endogenous Hyperinsulinaemic Hypoglycaemia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endogenous Hyperinsulinaemic Hypoglycaemia focused on measuring Localisation of Insulinoma, beta-cell imaging, exendin-4, 68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ga -exendin PET/CT, In- exendin SPECT/CT, MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Measuring Tumour to Background Ratio
Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.

Secondary Outcome Measures

Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT
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)
Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4
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-4 SPECT/CT
Comparison of the angiogenesis markers with the those of breast carcinoma patients

Full Information

First Posted
February 10, 2014
Last Updated
April 16, 2018
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Insel Gruppe AG, University Hospital Bern, Desirée and Niels Yde's Foundation, Zürich, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT02127541
Brief Title
New Imaging Procedure for the Localisation of Insulinoma
Official Title
New Imaging Procedure for the Localisation of Insulinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 6, 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Insel Gruppe AG, University Hospital Bern, Desirée and Niels Yde's Foundation, Zürich, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endogenous Hyperinsulinaemic Hypoglycaemia
Keywords
Localisation of Insulinoma, beta-cell imaging, exendin-4, 68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
Other Intervention Name(s)
68Ga-DOTA-exendin-4, 111In-DOTA-exendin-4, MRI
Intervention Description
Comparison of different imaging modalities
Primary Outcome Measure Information:
Title
Measuring Tumour to Background Ratio
Time Frame
4 years
Title
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 Measure Information:
Title
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
Title
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
Title
Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4
Description
Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system
Time Frame
4 years
Title
Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT
Time Frame
4 years
Title
Comparison of the angiogenesis markers with the those of breast carcinoma patients
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Wild, MD, PhD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18703486
Citation
Wild D, Macke H, Christ E, Gloor B, Reubi JC. Glucagon-like peptide 1-receptor scans to localize occult insulinomas. N Engl J Med. 2008 Aug 14;359(7):766-8. doi: 10.1056/NEJMc0802045. No abstract available.
Results Reference
background
PubMed Identifier
19820010
Citation
Christ E, Wild D, Forrer F, Brandle M, Sahli R, Clerici T, Gloor B, Martius F, Maecke H, Reubi JC. Glucagon-like peptide-1 receptor imaging for localization of insulinomas. J Clin Endocrinol Metab. 2009 Nov;94(11):4398-405. doi: 10.1210/jc.2009-1082. Epub 2009 Oct 9.
Results Reference
background
PubMed Identifier
20860517
Citation
Pattou F, Kerr-Conte J, Wild D. GLP-1-receptor scanning for imaging of human beta cells transplanted in muscle. N Engl J Med. 2010 Sep 23;363(13):1289-90. doi: 10.1056/NEJMc1004547. No abstract available.
Results Reference
background
PubMed Identifier
24622317
Citation
Christ E, Wild D, Ederer S, Behe M, Nicolas G, Caplin ME, Brandle M, Clerici T, Fischli S, Stettler C, Ell PJ, Seufert J, Gloor B, Perren A, Reubi JC, Forrer F. Glucagon-like peptide-1 receptor imaging for the localisation of insulinomas: a prospective multicentre imaging study. Lancet Diabetes Endocrinol. 2013 Oct;1(2):115-22. doi: 10.1016/S2213-8587(13)70049-4. Epub 2013 Jul 25.
Results Reference
background
PubMed Identifier
31298706
Citation
Antwi K, Nicolas G, Fani M, Heye T, Pattou F, Grossman A, Chanson P, Reubi JC, Perren A, Gloor B, Vogt DR, Wild D, Christ E. 68Ga-Exendin-4 PET/CT Detects Insulinomas in Patients With Endogenous Hyperinsulinemic Hypoglycemia in MEN-1. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5843-5852. doi: 10.1210/jc.2018-02754.
Results Reference
derived
PubMed Identifier
30449018
Citation
Valente LG, Antwi K, Nicolas GP, Wild D, Christ E. Clinical presentation of 54 patients with endogenous hyperinsulinaemic hypoglycaemia: a neurological chameleon (observational study). Swiss Med Wkly. 2018 Nov 18;148:w14682. doi: 10.4414/smw.2018.14682. eCollection 2018 Nov 5.
Results Reference
derived
PubMed Identifier
30054698
Citation
Antwi K, Fani M, Heye T, Nicolas G, Rottenburger C, Kaul F, Merkle E, Zech CJ, Boll D, Vogt DR, Gloor B, Christ E, Wild D. Comparison of glucagon-like peptide-1 receptor (GLP-1R) PET/CT, SPECT/CT and 3T MRI for the localisation of occult insulinomas: evaluation of diagnostic accuracy in a prospective crossover imaging study. Eur J Nucl Med Mol Imaging. 2018 Dec;45(13):2318-2327. doi: 10.1007/s00259-018-4101-5. Epub 2018 Jul 28.
Results Reference
derived

Learn more about this trial

New Imaging Procedure for the Localisation of Insulinoma

We'll reach out to this number within 24 hrs