Clinical trial NCT02127541: New Imaging Procedure for the Localisation of Insulinoma
Official title: New Imaging Procedure for the Localisation of Insulinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endogenous Hyperinsulinaemic Hypoglycaemia
Keywords: Localisation of Insulinoma
beta-cell imaging
exendin-4
68Ga-DOTA-exendin-4 PET/CT
111In-DOTA-exendin-4 SPECT/CT
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Desirée and Niels Yde's Foundation, Zürich, Switzerland
First posted: 2014-04-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Measuring Tumour to Background Ratio
timeFrame: 4 years
measure: Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.
timeFrame: 4 years
Secondary outcomes:
measure: Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT
timeFrame: 4 years
measure: 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)
timeFrame: 4 years
measure: Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4
timeFrame: 4 years
measure: Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT
timeFrame: 4 years
measure: Comparison of the angiogenesis markers with the those of breast carcinoma patients
timeFrame: 4 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Damian Wild, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.