Effect of Gelofusine on GLP1-receptor Imaging
GLP1-EX-GELO
Effect of Gelofusine on 111In-DTPA-AHX-Lys40-Exendin 4 Uptake in the Kidney
2 other identifiers
interventional
12
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 31, 2017
May 1, 2017
1.8 years
March 3, 2015
May 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal uptake as measured by uptake of 111In-exendin-4 on SPECT images and without co-infusion of Gelofusine.
up to 8 months
Secondary Outcomes (1)
Pancreas uptake as measured by uptake of 111In-exendin-4 on SPECT images
up to 8 months
Study Arms (2)
gelofusine and 111In-exendin 4 SPECT/CT
EXPERIMENTALsubjects will receive a gelofusine injection before the injection of the radiopharmaceutical (111In-exendin 4)
saline and 111In-exendin 4 SPECT/CT
PLACEBO COMPARATORAs a control, subjects will receive an injection of saline before the injection of the radiopharmaceutical (111In-exendin 4)
Interventions
111In-exendin 4 SPECT/CT
Eligibility Criteria
You may qualify if:
- \>= 18 years
- \<= 60 years
- Normal renal function
- Normal glucose regulation
- BMI 17\>30
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Gotthardt, Prof Dr
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2015
First Posted
September 4, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 31, 2017
Record last verified: 2017-05