drugset / Trial / NCT02541734

Effect of Gelofusine on GLP1-receptor Imaging

NCT02541734

Phase 1/2 Completed 12 enrolled Radboud University Medical Center
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2015-08
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Gelofusine Other / unclassified