NCT04733508

Brief Summary

Validation of the exendin-based beta cell imaging technique in patients with type 2 diabetes

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 2, 2021

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

October 8, 2020

Last Update Submit

January 28, 2021

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Keywords

nuclear imagingbeta cell massexendin-4

Outcome Measures

Primary Outcomes (7)

  • Pancreatic exendin uptake 111In-DTPA exendin-4

    The pancreatic uptake of 111In-DTPA-exendin-4 will be quantified using ex vivo SPECT

    111In-DTPA-exendin-4 injection will be performed a day before planned surgery, and uptake will be determined using ex vivo SPECTof the resected tissue one day after surgery

  • Pancreatic exendin uptake 111In-DTPA exendin-4

    The pancreatic uptake of 111In-DTPA-exendin-4 will be quantified using tissue autoradiography

    111In-DTPA-exendin-4 injection will be performed a day before planned surgery, and uptake will be determined with tissue autoradiography immediately after resection

  • Beta cell function

    The beta cell function will be determined with a glucose tolerance test

    The glucose tolerance test will be performed within a week before planned surgery

  • Blood glucose levels

    Glycemic control will be determined by monitoring blood glucose levels

    Blood glucose levels will be continuously monitored a week prior to surgery

  • HbA1C levels

    HbA1C levels will be determined as a measure of glycemic control

    HbA1C levels will be determined within a week before planned surgery

  • Pancreatic exendin uptake IRDye800CW-exendin-4

    Uptake of IRDye800CW-exendin4 will be visualized with microscopy

    IRDye800CW-exendin-4 injection will be performed a day before planned surgery, and uptake will be determined using microscopy in the excised tissue

  • Gene expression

    Gene expression levels will be determined with quantitative polymerase chain reaction (qPCR)

    Gene expression will be determined in the excised pancreatic tissue immediately after resection

Study Arms (2)

111In-exendin-DTPA

EXPERIMENTAL

Injection of 111In-exendin-DTPA for subsequent localization of the tracer in excised tissue using autoradiography

Drug: 111In-DTPA-exendin-4

exendin-IRDye800CW

EXPERIMENTAL

Injection of exendin-4-IRDye800CW for subsequent localization of the tracer in excised tissue using fluorescence microscopy

Drug: IRDye800CW-exendin-4

Interventions

111In-DTPA-exendin-4DRUG

Injection of 111In-DTPA-exendin-4 and localization of the tracer in excised pancreatic tissue using autoradiography

111In-exendin-DTPA
IRDye800CW-exendin-4DRUG

Injection of IRDye800CW-exendin-4 and localization of the tracer in excised pancreatic tissue using fluorescence microscopy

exendin-IRDye800CW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for partial or complete pancreatectomy at Radboudumc

You may not qualify if:

  • Previous treatment with synthetic exendin or dipeptidyl-peptidase IV inhibitors within the past 3 months
  • Breast feeding
  • Pregnancy or the wist to become pregnant within 6 months
  • Creatinine clearance below 40ml/min
  • Liver disease defined as aspartate aminotransferase of alanine aminotransferase level of more than three times the upper limit of normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

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

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Sanne van Lith, PhD

CONTACT

0031243613813sanne.vanlith@radboudumc.nl

Martin Gotthardt, MD, prof

CONTACT

Martin.Gotthardt@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

February 2, 2021

Study Start

November 1, 2019

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

February 2, 2021

Record last verified: 2020-10

Locations

NL(1)