Study Comparing Fluciclovine (18F) and Fluoroethyltyrosine F-18 PET Scans in Patients with New or Recurrent Brain Tumors and Brain Metastases

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What is this study about?

This clinical trial is focused on studying brain tumors, specifically cerebral gliomas and brain metastases. The trial involves patients who have been newly diagnosed with these conditions or have experienced a recurrence. The study will use two different imaging agents, 18F-Fluciclovine and 18F-Fluoroethyltyrosine, both of which are solutions for injection. These agents help in visualizing the tumors during a type of scan called a PET scan, which stands for Positron Emission Tomography. The purpose of the study is to compare how well these two agents work in showing the size and spread of the tumors in the brain.

Participants in the study will receive injections of these imaging agents, and then undergo PET scans. The study will look at how the images from the two different agents compare in terms of showing the tumor’s size and how the agent spreads in the brain. This will help doctors understand which agent might be more effective for certain types of brain tumors. The study is designed to be open-label, meaning both the participants and the researchers know which agent is being used.

The trial aims to gather information over a period of time to see if there is a significant correlation between the results from the two agents. It will also assess how accurately these agents can differentiate between tumor growth and changes related to previous treatments. This information could be valuable in improving the diagnosis and treatment planning for patients with brain tumors.

1 initial assessment

Upon joining the study, the patient will undergo an initial assessment to confirm eligibility. This includes verifying age, mental and physical ability to understand the study, decision-making capacity, and obtaining informed consent.

The patient must be referred to the Nuclear Medicine Clinic for a brain scan based on a physician’s prescription, with suspected glioma or tumor recurrence.

2 first imaging session

The patient will receive an intravenous injection of FET (fluoroethyltyrosine f-18) solution for injection. This is a type of imaging agent used in PET scans to help visualize brain tumors.

The imaging session will assess the size and distribution of the tumor using the FET PET scan.

3 second imaging session

The patient will receive an intravenous injection of Axumin (fluciclovine (18f)) solution for injection. This is another imaging agent used in PET scans.

The imaging session will assess the size and distribution of the tumor using the FACBC PET scan.

4 data analysis

The primary goal is to compare the results of the FET PET and FACBC PET scans to determine agreement on tumor size and tracer distribution.

The results will be evaluated by three examiners to reach a consensus on the classification of the tumor.

5 follow-up

The study will monitor the correlation of tumor-to-brain ratios and other metrics such as time-to-peak and slope of the time-activity-curve in both high-grade and low-grade gliomas.

The accuracy of the imaging methods in differentiating tumor progression from treatment-related changes will also be assessed.

Who Can Join the Study?

The patient must be 18 years old or older.
The patient must be mentally and physically able to understand the importance and details of the study and follow the instructions of the study staff.
The patient must have the ability to make decisions, meaning they can give consent, understand, and provide information.
The patient must have signed a written informed consent form before joining the study. This means they agree to participate after understanding what the study involves.
The patient must be referred to the Nuclear Medicine Clinic of the University Hospital Aachen for a specific brain scan called FET PET, based on their doctor’s recommendation.
The patient must have a suspected glioma (a type of brain tumor) before having a biopsy or surgery. OR
The patient must have a suspected tumor recurrence, meaning the tumor might have come back after previous treatment for a brain tumor or brain metastasis (cancer that has spread to the brain).

Who Cannot Join the Study?

Patients who do not have newly diagnosed or recurrent cerebral gliomas (a type of brain tumor) or brain metastases (cancer that has spread to the brain from another part of the body).
Individuals who are not within the specified age range for the study.
Participants who are not part of the specified clinical trial groups.
People who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitaetsklinikum Aachen AöR	Aachen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.03.2024

Trial locations

Investigated drugs:

18F-Fluciclovine is a type of imaging agent used in PET scans. It helps doctors see certain types of brain tumors more clearly. In this trial, it is used to compare how well it can show the size and spread of brain tumors compared to another imaging agent.

18F-Fluoroethyltyrosine is another imaging agent used in PET scans. Like 18F-Fluciclovine, it helps in visualizing brain tumors. The trial aims to see how effectively it can show the size and distribution of brain tumors compared to 18F-Fluciclovine.

Investigated diseases:

Glioma

Cerebral Gliomas – These are tumors that originate in the brain’s glial cells, which support and protect neurons. They can vary in their growth rate and aggressiveness, with some being slow-growing and others more rapid. As they progress, they may cause symptoms such as headaches, seizures, or changes in personality, depending on their location in the brain. The progression can lead to increased pressure within the skull and affect brain function. Gliomas are classified into different grades, with higher grades being more aggressive.

Brain Metastases – These occur when cancer cells spread to the brain from another part of the body. They can form one or multiple tumors within the brain tissue. As they grow, they may disrupt normal brain function, leading to symptoms like headaches, seizures, or neurological deficits. The progression of brain metastases can vary depending on the primary cancer type and the number of metastases. They can cause swelling and increased pressure in the brain, affecting overall health. Brain metastases are a common complication of cancers such as lung, breast, and melanoma.

Trial ID:

2023-507786-26-00

Protocol code:

23-096

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Fluciclovine (18F) and Fluoroethyltyrosine F-18 PET Scans in Patients with New or Recurrent Brain Tumors and Brain Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?