Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin

Not Applicable

Terminated

• Conditions: Diabetes Mellitus
• Interventions: Radiation: indium-111-exendin SPECT/CT

• Registration Number: NCT03889496
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The main goal is to study the correlation of pancreatic uptake of In-111-DTPA-exendin-4 (measured by ex vivo counting) with the beta cell mass determined in the pancreatic specimens obtained after surgery.

Detailed Description

In order to fully characterize the highly promising tracer In-111-DTPA-exendin-4 in humans, quantitative SPECT imaging will be correlated to the ex vivo tracer distribution in patients undergoing pancreatectomy or a Whipple procedure. In vivo imaging will be combined with post-pancreatectomy (micro)autoradiography, measurement of In-111-DTPA-exendin-4 concentrations in the pancreas using a gamma counter and morphometric determination of the actual beta cell mass. By this means, the relation between tracer uptake and beta cell mass in non-diabetic patients and T2D patients will be established. These highly relevant data will allow the improvement of the interpretation of clinical quantitative SPECT data in subsequent studies in patients with T1D and T2D. In addition, high uptake has been observed in the duodenum/pyloric area in patients in an ongoing study. At this point in time, it remains unclear which cells are responsible for this uptake. It would be of great interest to identify the GLP-1R positive cells in order to better understand the physiological actions of GLP-1 agonists.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11-16
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-26
• Status Verified: 2020-10
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc

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Exclusion Criteria

• Resection that provides insufficient amount of tissue
• Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl- Peptidase IV inhibitors
• Breast feeding
• Pregnancy or the wish to become pregnant within 6 months
• Renal disease
• Liver disease
• Age < 18 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scheduled for (partial) pancreatectomy or Whipple procedure	indium-111-exendin SPECT/CT	I.v. injection with In-111-DTPA-exendin-4 and SPECT/CT scan

Primary Outcome Measures

Name	Time	Method
Correlation between the tracer uptake (counts) and beta cell mass (mg)	4 years	The primary objective is the correlation between the ex vivo In-111-exendin tracer accumulation in the pancreas (counts) of patients undergoing pancreatectomy or Whipple procedure, and the beta cell mass (mg) in non- diabetic patients and patients with diabetes.

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands