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InsulinomaPhase 1/2GLP-1-AHHNCT03189953

68Ga-NODAGA-exendin-4 PET/CT for Diagnostic Imaging in AHH

A Phase 1/2 study testing 68Ga-NODAGA-exendin 4 PET/CT in people with Insulinoma, run by Radboud University Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In order to improve the sensitivity and specificity of pre-operative imaging localization of foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R), 68Ga-NODAGA-exendin 4. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insulinoma
What is being tested?
68Ga-NODAGA-exendin 4 PET/CT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Apr 2015to May 2021
Phase
Phase 1/2
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

  • Biochemically proven endogenous hyperinsulinemic hypoglycemia
  • Signed informed consent
  • Standard imaging not older than 8 weeks.

Who cannot join

  • Breast feeding
  • Pregnancy or the wish to become pregnant within 6 months
  • Calculated creatinine clearance below 40ml/min
  • Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions)
  • Age < 18 years
  • No signed informed consent

About this study

Official title: 68Ga-NODAGA-exendin-4 PET/CT in Patients With AHH - a Prospective Comparative Evaluation of Preoperative Imaging

In order to improve the sensitivity and specificity of pre-operative imaging localization of foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R), 68Ga-NODAGA-exendin 4. With the currently used imaging techniques, only about 70-80% of insulin producing pancreatic neuroendocrine tumors (IPPNET) can be successfully visualized. Therefore, we propose to compare GLP-1R PET imaging to the standard imaging techniques in patients scheduled for surgical removal of the tumour. These highly relevant data will allow us to interpret the benefits of GLP-1R-imaging over other imaging techniques for the diagnosis of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains challenging and frequently still leading to futile surgery or unnecessary partial pancreatectomy, a more sensitive and specific imaging technique would be of great value.

Read the detailed description

Adult endogenous hyperinsulinaemic hypoglycaemia The most common form of functional neuroendocrine tumours of the pancreas are insulin producing pancreatic neuroendocrine tumors (IPPNET). These tumors are rare and have an incidence of 1-4 newly diagnosed cases per 1 million per year and are malignant in about 10% of the cases. Another cause of AHH is nesidioblastosis, or adult beta cell hyperplasia. It is difficult to exactly determine the incidence of the disease, but it appears that in approximately 5% of the cases of AHH nesiodioblastosis may be the underlying pathology, while IPPNET are responsible for the majority of the cases. The pathophysiological cause of nesidioblastosis is not well understood, but the rising incidence of the AHH as a consequence of gastric bypass surgery for morbid obesity (although often reversible in these patients) may suggest an association with metabolic and hormonal changes.

For IPPNET, surgical removal of the tumour is the therapy of choice and is considered curative in case of a benign tumour. Optimal preoperative localization of the lesion is warranted in order to reduce morbidity by helping to optimize the surgical procedure. Successful preoperative localization of IPPNET is a challenging problem since approximately 30% of IPPNET cannot be visualized using the conventional imaging techniques CT and/or MRI and endoscopic ultrasound. Selective arterial stimulation with calcium with simultaneous venous sampling (ASVS) has been described to have a sensitivity and specificity of almost 90% in identifying IPPNET. This is, however, an invasive technique which is accompanied by an risk for complications. Functional imaging with somatostatin (sst) receptor scintigraphy (SRS) and SPECT/CT are able to detect less than 50% of benign IPPNET because of low or absent expression of sst receptor subtypes 2 and 5, which bind octreotide with high affinity. PET with 68Ga-labeled sst analogs has a higher sensitivity for smaller lesions than SRS. Also 11C-5-HTP and 18F-DOPA, which are used as PET tracers for the detection of IPPNET in some centers may be more sensitive than SRS and CT with 11C-5-HTP showing the most accurate visualization. However, when compared to intra-operative findings, 2 out of 6 IPPNET could still not be detected preoperatively. Palpation and intra-operative ultrasound will allow identifying the lesion in approximately 70-80% of cases. However, it remains a challenge to find small or multiple tumours in the pancreas and partial pancreatectomy is frequently required, especially if the lesion is located close to the pancreatic duct. Precise preoperative localization of the IPPNET is therefore critical to minimize surgical intervention. If no IPPNET can be identified pre- or perioperatively, the diagnosis of nesidioblastosis may be established by resection and histopathologic evaluation of the pancreatic tail. If nesidioblastosis is present, partial pancreatectomy is required; the challenge is to remove enough tissue in order to avoid hypoglycaemia while keeping enough functional endocrine pancreatic tissue so that the patient does not become diabetic. Currently, with the risk of reoperation being considered lower than the consequences and complications of diabetes, surgeons usually choose a fairly conservative approach.

Imaging of diseased beta cells Visualization of the beta cells by a highly specific radiotracer with which high target-to background ratios can be obtained would benefit preoperative visualization of IPPNET in patients with AHH. Reliable visualization of diseased beta cells would then benefit the optimization of treatment of patients with AHH. An innovative method for imaging of beta cells could allow to optimally guide surgical interventions In addition, this novel approach could lead to a minimization of side-effects from the treatment.

Targeting of the GLP-1 receptor In this study we will compare the sensitivity and specificity of pre-operative imaging of IPPNET by GLP-1R scanning to the current standard imaging techniques.

Conditions
Insulinoma
Being tested
68Ga-NODAGA-exendin 4 PET/CT
Medical subject headings
Insulinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-NODAGA-exendin 4 PET/CTRadiation

    68Ga-NODAGA-exendin 4 PET/CT

Study groups in NCT03189953
Study groupRoleWhat they receive
68Ga-NODAGA-exendin PET/CTExperimental68Ga-NODAGA-exendin PET/CT
Receives: Radiation: 68Ga-NODAGA-exendin 4 PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor visualization by 68Ga-NODAGA-exendin-4 PET/CT and standard imaging

    Measured: 1 year

Secondary outcomes (4)
  1. Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4

    Measured: 1 year

  2. Retrospective surgery planning, type of surgery based on image analysis

    Measured: 1 year

  3. Calculation and comparison of the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT and EUS combined with triple phase CT or MRI

    Measured: up to 24 months

  4. GLP-1 receptor expression by histology compared to tracer uptake

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study startApr 2015
  3. Primary completionJan 2021
  4. Study completionMay 2021

Resources

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 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Comparison of 68Ga-NODAGA-exendin PET/CT with standard diagnostic methods
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03189953
Sponsor's protocol ID
NL50643.091.14
Other IDs
2014-003167-38, 602812, 2014
Acronym
GLP-1-AHH
Status last verified
Jun 2021
First submitted
6 Apr 2016
Last updated
16 Jun 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 68Ga-NODAGA-exendin 4 PET/CT in people with Insulinoma, run by Radboud University Medical Center.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tumor visualization by 68Ga-NODAGA-exendin-4 PET/CT and standard imaging (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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