Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin (GLP1-ex-vivo)

Radboud University Medical Center

Status: Terminated

Conditions: Diabetes Mellitus

Treatments: Radiation: indium-111-exendin SPECT/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03889496

NL47132.091.14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Scheduled for (partial) pancreatectomy or Whipple procedure

Other group

Description:

I.v. injection with In-111-DTPA-exendin-4 and SPECT/CT scan

Treatment:

Radiation: indium-111-exendin SPECT/CT