Diabetes MellitusGLP1-ex-vivoNCT03889496
Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin
A study testing indium-111-exendin SPECT/CT in people with Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- indium-111-exendin SPECT/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Nov 2015to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- indium-111-exendin SPECT/CT
- Keywords
- exendin-4, GLP-1 receptor imaging, SPECT, pancreas, surgery, quantification
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indium-111-exendin SPECT/CTRadiation
SPECT/CT imaging after injection with In-111-DTPA-exendin-4
| Study group | Role | What they receive |
|---|---|---|
| Scheduled for (partial) pancreatectomy or Whipple procedure | Other | I.v. injection with In-111-DTPA-exendin-4 and SPECT/CT scan Receives: Radiation: indium-111-exendin SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start16 Nov 2015
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Gotthardt, Prof. Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889496
- Sponsor's protocol ID
- NL47132.091.14
- Acronym
- GLP1-ex-vivo
- Status last verified
- Oct 2020
- First submitted
- 23 Jan 2019
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39405026
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin
- ClinicalTrials.gov ID
- NCT03889496
- Acronym / sponsor ID
- GLP1-ex-vivo / NL47132.091.14
- Conditions
- Diabetes Mellitus
- Keywords
- exendin-4, GLP-1 receptor imaging, SPECT, pancreas, surgery, quantification
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scheduled for (partial) pancreatectomy or Whipple procedure | Other | Radiation: indium-111-exendin SPECT/CTI.v. injection with In-111-DTPA-exendin-4 and SPECT/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indium-111-exendin SPECT/CTSPECT/CT imaging after injection with In-111-DTPA-exendin-4 | Radiation | Scheduled for (partial) pancreatectomy or Whipple procedure |
Primary outcome
Correlation between the tracer uptake (counts) and beta cell mass (mg)
Time frame: 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.
Results and safety
The study was stopped early (reason given: Because of the COVID-19 pandemic, funding for the trial was terminated and attempts to find alternative sources of funding were to no avail.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 39405026Jansen 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Gotthardt, Prof. Dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indium-111-exendin SPECT/CT in people with Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of the COVID-19 pandemic, funding for the trial was terminated and attempts to find alternative sources of funding were to no avail.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the tracer uptake (counts) and beta cell mass (mg) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.