Completed

NCT Number: NCT02127541

New Imaging Procedure for the Localisation of Insulinoma

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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Key information

Conditions

Endogenous Hyperinsulinaemic Hypoglycaemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

Comparison of different imaging modalities

Other names: 68Ga-DOTA-exendin-4, 111In-DOTA-exendin-4, MRI

Primary outcomes

Measuring Tumour to Background Ratio

Time frame: 4 years
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

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
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
Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4

Time frame: 4 years

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

Time frame: 4 years
Comparison of the angiogenesis markers with the those of breast carcinoma patients

Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

Desirée and Niels Yde's Foundation, Zürich, Switzerland
Insel Gruppe AG, University Hospital Bern

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Apr 30, 2014
Registry last updated: Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.