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CompletedNCT02127541Updated Apr 18, 2018

New Imaging Procedure for the Localisation of Insulinoma

An interventional study of Ga -exendin PET/CT, In- exendin SPECT/CT, MRI in Endogenous Hyperinsulinaemic Hypoglycaemia, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Endogenous Hyperinsulinaemic Hypoglycaemia

Keywords

  • Localisation of Insulinoma
  • beta-cell imaging
  • exendin-4
  • 68Ga-DOTA-exendin-4 PET/CT
  • 111In-DOTA-exendin-4 SPECT/CT
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In context

Insulinoma

45 studies on the registry are indexed under Insulinoma; 12 are open to participants now.

This study's enrollment of 52 is close to the median of 50 across 29 interventional studies indexed under Insulinoma.

Browse Insulinoma studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • 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

Interventions

  • OtherGa -exendin PET/CT, In- exendin SPECT/CT, MRI

    Comparison of different imaging modalities

    Also known as: 68Ga-DOTA-exendin-4, 111In-DOTA-exendin-4, MRI

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What researchers measure

Primary outcomes

  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 outcomes

  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

    Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system

    Time frame: 4 years

  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

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Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

References and documents

Publications

  • 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. PubMed 18703486 ↗
  • 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. PubMed 19820010 ↗
  • 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. PubMed 20860517 ↗
  • 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. PubMed 24622317 ↗
  • 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. PubMed 31298706 ↗
  • 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. PubMed 30449018 ↗
  • 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. PubMed 30054698 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02127541
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Insel Gruppe AG, University Hospital Bern, Desirée and Niels Yde's Foundation, Zürich, Switzerland
Responsible party
Sponsor
First posted
Apr 30, 2014
Start date
Jan 6, 2014
Primary completion
Nov 2017
Completion
Nov 2017
Last update
Apr 18, 2018

Study contacts

Damian Wild, MD, PhD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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