Endogenous Hyperinsulinaemic Hypoglycaemia Clinical Trial
Official title:
New Imaging Procedure for the Localisation of Insulinoma
| Verified date | April 2018 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | Desirée and Niels Yde's Foundation, Zürich, Switzerland, University Hospital Inselspital, Berne |
Switzerland,
Christ E, Wild D, Ederer S, Béhé M, Nicolas G, Caplin ME, Brändle 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. — View Citation
Christ E, Wild D, Forrer F, Brändle 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. — View 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. — View Citation
Wild D, Mäcke 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measuring Tumour to Background Ratio | 4 years | ||
| Primary | Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT. | 4 years | ||
| Secondary | Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT | 4 years | ||
| Secondary | 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) | 4 years | ||
| Secondary | 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 | 4 years | |
| Secondary | Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT | 4 years | ||
| Secondary | Comparison of the angiogenesis markers with the those of breast carcinoma patients | 4 years |