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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Stichting Radboud University Medical Center	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	22.12.2021

Trial locations

Investigated drugs:

Exenatide

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.

Investigated diseases:

Paraganglion neoplasm

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.

Trial ID:

2024-516755-40-00

NCT ID:

NCT05418907

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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