Effect of Gelofusine on GLP1-receptor Imaging

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The highly promising and innovative tracer on 111In-DTPA-AHX-Lys40-Exendin 4 has been applied to determine beta cell mass in healthy volunteers and patients with type 1 diabetes. However, the high retention of the tracer in the kidneys was leading to a kidney/pancreas uptake ratio of 41±23. This high renal uptake is complicating absolute BCM quantification by SPECT imaging. In order to reduce the kidney/pancreas uptake ratio, investigators propose a co-infusion with the plasma expander Gelofusine since it has been shown in several pre-clinical and clinical studies that Gelofusine can reduce the renal retention of several other, closely related tracers. When investigators are able to reduce the kidney/pancreas uptake ratio, these findings will improve the interpretation of clinical quantitative SPECT, having important implications for therapeutic decision making for patients with diabetes, insulinomas or congenital hyperinsulinism, and may also have a major impact on our understanding of the pathophysiology of these diseases.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University
• Treatments: Exenatide; Polygeline; Radiopharmaceuticals

Criteria

Inclusion Criteria:

• >= 18 years

• <= 60 years

• Normal renal function

• Normal glucose regulation

• BMI 17>30

Exclusion Criteria:

• Use of any medication affecting renal function

• Known hypersensitivity to one of the substances used

• Hypertension

• Oedema

• Hypervolaemia

• Heart failure

• Pregnancy or the wish to become pregnant within 3 months after participation of the study.

• Lactation

• History of anaphylaxis

• Liver disease defined as aspartate aminotransferase or alanine aminotransferase level more than 3 times the upper limit of normal range (45U/L)