Determination of the effect of Gelofusine on the kidney uptake of a radioactive tracer molecule used for imaging of insulin producing beta-cells in the pancreas

Effect of Gelofusine on 111In-DTPA-AHX-Lys40-Exendin 4 uptake in the kidney - Effect of Gelofusine on GLP1-receptor imaging

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003006-33-NL

Enrollment

Registered

2015-02-09

Start date

2015-02-16

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The aim of this study is to reduce the kidney uptake during 111In-DTPA- exendin4 imaging, a promising and valuable tool for beta-cell mass imaging and quantification, which can be applied in patients with e.g. diabetes. MedDRA version: 17.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 17.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) Syst

Interventions

Trade Name: Byetta Product Name: 111-In-DTPA-[k40]-Exendin4 Pharmaceutical Form: Radiopharmaceutical precursor, solution Trade Name: Gelofusine Pharmaceutical Form: Infusion Pharmaceutical form of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • >= 18 years • 90mL/min according to the formula of Cockroft and Gault) • Normal glucose regulation (HbA1c 53 /mol (7%)) • BMI 17>30 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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) • History of pancreatitis

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine whether the administration of Gelofusine will reduce the kidney uptake of 111Inlabeled exendin in humans by enhancing the excretion of 111In-labeled exendin. These highly relevant data can potentially improve the interpretation of clinical quantitative SPECT and can have important implications for imaging of pancreatic beta cell mass in diabetes patients as well as therapeutic decision making for patients with insulinomas or congenital hyperinsulinism.;Secondary Objective: Determine whether the administration of Gelofusine affects pancreatic uptake of 111In-labeled exendin based on quantitative analysis of SPECT images.;Primary end point(s): The main study parameter is the renal uptake of 111In-DTPA-[K40]-Exendin 4 based on quantitative SPECT imaging with and without co-infusion of Gelofusine.;Timepoint(s) of evaluation of this end point: In total patients will undergo two exendin injections : one with gelofusine and one with saline as a control (the order will be randomly assigned). There will be at least three weeks between the exendin injections to prevent influence of the previous injection. The first two patients will undergo two SPECT-scans after exendin injections (four scans in total): 4h and 24h post injection. Based on these data one time-point for analysis is selected and the other patients will receive two scans in total.	—

Measure

Time frame

Main Objective: The primary objective is to determine whether the administration of Gelofusine will reduce the kidney uptake of 111Inlabeled exendin in humans by enhancing the excretion of 111In-labeled exendin. These highly relevant data can potentially improve the interpretation of clinical quantitative SPECT and can have important implications for imaging of pancreatic beta cell mass in diabetes patients as well as therapeutic decision making for patients with insulinomas or congenital hyperinsulinism.;Secondary Objective: Determine whether the administration of Gelofusine affects pancreatic uptake of 111In-labeled exendin based on quantitative analysis of SPECT images.;Primary end point(s): The main study parameter is the renal uptake of 111In-DTPA-[K40]-Exendin 4 based on quantitative SPECT imaging with and without co-infusion of Gelofusine.;Timepoint(s) of evaluation of this end point: In total patients will undergo two exendin injections : one with gelofusine and one with saline as a control (the order will be randomly assigned). There will be at least three weeks between the exendin injections to prevent influence of the previous injection. The first two patients will undergo two SPECT-scans after exendin injections (four scans in total): 4h and 24h post injection. Based on these data one time-point for analysis is selected and the other patients will receive two scans in total.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary study parameter is the pancreatic uptake of 111In-DTPA-[K40]-Exendin 4 based on quantitative SPECT imaging with and without co-infusion of Gelofusine.;Timepoint(s) of evaluation of this end point: In total patients will undergo two exendin injections : one with gelofusine and one with saline as a control (the order will be randomly assigned). There will be at least three weeks between the exendin injections to prevent influence of the previous injection. The first two patients will undergo two SPECT-scans after exendin injections (four scans in total): 4h and 24h post injection. Based on these data one time-point for analysis is selected and the other patients will receive two scans in total.	—

Measure

Time frame

Secondary end point(s): The secondary study parameter is the pancreatic uptake of 111In-DTPA-[K40]-Exendin 4 based on quantitative SPECT imaging with and without co-infusion of Gelofusine.;Timepoint(s) of evaluation of this end point: In total patients will undergo two exendin injections : one with gelofusine and one with saline as a control (the order will be randomly assigned). There will be at least three weeks between the exendin injections to prevent influence of the previous injection. The first two patients will undergo two SPECT-scans after exendin injections (four scans in total): 4h and 24h post injection. Based on these data one time-point for analysis is selected and the other patients will receive two scans in total.

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Countries

Netherlands

Contacts

Public ContactDepartment of Nuclear Medicine

Radboud University Medical Center

mijke.buitinga@radboudumc.nl0031243661319

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026