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NCT03889496 Clinical Trial

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

Diabetes Mellitus Clinical Trial

— GLP1-ex-vivo  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03889496
Other study ID # NL47132.091.14
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 16, 2015
Est. completion date June 14, 2021

Study information
Verified date October 2020
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date June 14, 2021
Est. primary completion date June 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• indium-111-exendin SPECT/CT
SPECT/CT imaging after injection with In-111-DTPA-exendin-4

Locations
Country Name City State
Netherlands Radboud university medical center Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between the tracer uptake (counts) and beta cell mass (mg) 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. 4 years
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