Study Stopped
Because of the COVID-19 pandemic, funding for the trial was terminated and attempts to find alternative sources of funding were to no avail.
Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin
GLP1-ex-vivo
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Nov 2015
Longer than P75 for not_applicable diabetes-mellitus
1 active site
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
Study Start
First participant enrolled
November 16, 2015
CompletedFirst Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2021
CompletedJuly 12, 2023
October 1, 2020
5.6 years
January 23, 2019
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Scheduled for (partial) pancreatectomy or Whipple procedure
OTHERI.v. injection with In-111-DTPA-exendin-4 and SPECT/CT scan
Interventions
SPECT/CT imaging after injection with In-111-DTPA-exendin-4
Eligibility Criteria
You may qualify if:
- Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud university medical center
Nijmegen, Gelderland, 6525 GA, Netherlands
Related Publications (1)
Jansen TJP, Tokgoz S, Buitinga M, van Lith SAM, Joosten L, Frielink C, Smeets EMM, Stommel MWJ, van der Kolk MB, de Galan BE, Brom M, Boss M, Gotthardt M. Validation of radiolabelled exendin for beta cell imaging by ex vivo autoradiography and immunohistochemistry of human pancreas. EJNMMI Res. 2024 Oct 15;14(1):96. doi: 10.1186/s13550-024-01159-6.
PMID: 39405026DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Gotthardt, Prof. Dr.
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2019
First Posted
March 26, 2019
Study Start
November 16, 2015
Primary Completion
June 14, 2021
Study Completion
June 14, 2021
Last Updated
July 12, 2023
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share