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Study on Using Exenatide PET/CT Imaging for Detecting Paragangliomas in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of tumor called paragangliomas. These are rare tumors that can develop in nerve tissue. The study is testing a new imaging technique called Exendin PET/CT to see if it can effectively detect these tumors. The imaging technique uses a special substance called 68Ga-exendin-4, which is injected into the body to help highlight the tumors during the scan.

The purpose of the study is to determine if this new imaging method can successfully identify paragangliomas. Participants in the study will undergo the Exendin PET/CT scan, which involves a combination of positron emission tomography (PET) and computed tomography (CT) to create detailed images of the body. The study will also compare the results of this new method with other standard imaging techniques to see how well it performs.

Throughout the study, researchers will look at how well the Exendin PET/CT scan detects paragangliomas and determine the best time to perform the scan for optimal results. They will also explore how the imaging results relate to certain characteristics of the tumors, such as their genetic makeup. The study aims to provide valuable information that could improve the way paragangliomas are diagnosed in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The initial assessment involves confirming the presence of a single tumor through standard diagnostic imaging techniques. This step ensures that the tumor is a sympathetic paraganglioma (PGL) and that there is no evidence of metastatic disease.
A CT scan and SSTR PET/CT are performed as part of the standard diagnostic imaging process. These are considered the golden standard for diagnosing paragangliomas.
Step 2
Informed consent
The patient must be able to understand and sign an informed consent form. This document explains the details of the study, including its purpose, procedures, and potential risks and benefits.
Step 3
Administration of exenatide
The patient receives an intravenous bolus injection or IV infusion of exenatide. This medication is used as part of the imaging process to help detect paragangliomas.
The specific dosage and frequency of administration are determined by the study protocol and are designed to optimize imaging results.
Step 4
PET/CT imaging
The patient undergoes a 68Ga-exendin-4 PET/CT scan. This imaging technique is used to detect paragangliomas and assess their characteristics.
The primary goal is to determine the detection rate of paragangliomas using this method. Secondary objectives include identifying the optimal timepoint for imaging and comparing imaging parameters with other techniques.
Step 5
Surgery preparation
The patient is scheduled for surgery following the imaging process. This step is part of the standard treatment plan for paragangliomas.
The imaging results may be used to guide surgical planning and decision-making.
Step 6
Follow-up and analysis
The study includes follow-up assessments to analyze the imaging results. This involves comparing quantitative imaging parameters and correlating them with genetic and histological data.
The study aims to understand the relationship between GLP-1R expression and tracer uptake in paragangliomas, as well as the correlation between imaging results and the genetic origin of the tumors.

Who can join the trial?

7 criteria

Must have a confirmed case of **paragangliomas** (PGL), which is a type of tumor, with only one tumor found using regular imaging tests.
Must not have any signs of **metastatic disease**, meaning the cancer has not spread to other parts of the body.
Must have undergone both **CT** (a detailed imaging test) and **SSTR PET/CT** (a special imaging test considered the best standard for diagnosis).
Must be scheduled to have surgery.
Must be able to understand and sign a document agreeing to participate in the study, known as **informed consent**.
Both males and females can participate.
Participants should not belong to a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with paragangliomas cannot participate. Paragangliomas are rare tumors that can develop in certain parts of the body.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

68Ga-exendin-4 is a special imaging agent used in PET/CT scans. It helps doctors see certain types of tumors called paragangliomas (PGLs) in the body. This medication is not used to treat the tumors but to help in their detection by making them visible on the scan.

Exenatide

What is already known about the treatment

Exendin-4 – This medication is administered through a PET/CT scan, where it is used as a tracer to help visualize certain tumors. Currently, it is being studied for its effectiveness in detecting paragangliomas, a type of tumor. The main therapeutic indication is for imaging purposes, specifically to identify the presence and location of these tumors. At the molecular level, Exendin-4 binds to specific receptors on the tumor cells, allowing them to be seen on the scan. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

Paragangliomas – Paragangliomas are rare tumors that originate from the paraganglia, a collection of nerve cells that are part of the autonomic nervous system. These tumors can develop in various parts of the body, including the head, neck, and along the spine. Paragangliomas are often slow-growing and may not cause symptoms until they become large or affect nearby structures. They can sometimes produce hormones that lead to symptoms such as high blood pressure, headaches, and sweating. The progression of paragangliomas can vary, with some remaining stable for years while others may grow or spread to other parts of the body. Understanding the behavior of these tumors is crucial for managing their impact on health.