AuthorisedTherapeutic exploratory (Phase II)Interventional

[18F]mFBG PET-CT imaging of pheochromocytoma

This research study is investigating a new way to scan for pheochromocytoma, which is a rare type of tumour that grows in the adrenal glands. Researchers are using a special substance called [18F]mFBG, which has a tiny amount of a radioactive tracer, with a PET-CT scan. The main goal is to find out if this special scan can locate more of these tumours than the standard CT scans currently used before surgery. They'll be comparing the results of both types of scans with what doctors find when they remove the tumours. The study is also looking at how well the tracer works, how much radiation a person might receive, and if there are any side effects from the tracer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

05 Aug 2024

Pheochromocytoma – endocrine adrenal tumor

What is this study about?

This study is about improving how doctors find a specific type of tumour called a pheochromocytoma. These tumours are quite rare and grow in your adrenal glands, which are small glands located on top of your kidneys. Currently, doctors often use standard CT scans to find these tumours before surgery.

Researchers are testing a new scanning method that uses a special substance called [18F]mFBG. This substance contains a very small, safe amount of a radioactive tracer that can be seen on a PET-CT scan. The idea is that this tracer might be absorbed more by the tumour cells, making them show up more clearly on the scan. The main point of this study is to see if this new scan can detect more of these tumour areas compared to the standard CT scans. The results from both scans will then be checked against what doctors actually find during surgery.

The study also aims to work out the best time to do the PET-CT scan after giving the tracer, understand how the tracer highlights the tumour compared to lab tests of the tumour, estimate the amount of radiation involved, and check for any side effects from the tracer. This research is important because finding all the tumour areas accurately before surgery can help doctors plan the best treatment.

Key takeaways

This study evaluates a new PET-CT scan for pheochromocytoma.
It uses a special tracer ([18F]mFBG) to potentially find tumours better.
Compares new scan detection with standard CT scans and surgical findings.
Looks at the scan's effectiveness, safety, and radiation dose.
Aims to improve how these rare tumours are located before surgery.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older, with a diagnosis of pheochromocytoma. There is no upper age limit, meaning people of all adult ages can take part.

This study is open to both men and women. The specific details of your health condition and medical history would be reviewed by the study team to ensure this study is a good fit for you.

Further specific criteria would be discussed with you by your doctor to ensure your safety and that the study is appropriate for your individual circumstances.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with pheochromocytoma?
Are you male or female?
Are you able to undergo a PET-CT scan procedure?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive an injection of the special tracer, [18F]mFBG, which helps highlight the tumour areas. You would then undergo a PET-CT scan at specific time points, likely at 1 hour and 2 hours after the tracer injection, to see how it works.

Before this, you would have already had a conventional CT scan as part of your standard care. The study involves comparing the findings from your new PET-CT scan with your previous standard CT scan and, ultimately, with the tumour tissue that is removed during your surgery. The study team will also monitor you for any side effects after receiving the tracer.

There may be follow-up appointments to check on your well-being. The total duration of your active involvement in the study would likely revolve around the timing of your scans and monitoring before and after your surgery.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially more accurately mapping your pheochromocytoma, which could help your doctors plan your surgery. However, there are potential risks, including exposure to a low dose of radiation from the tracer and the PET-CT scan, similar to other medical imaging procedures. There's also a chance of side effects from the tracer itself, which the study will carefully monitor. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is pheochromocytoma?

It's a rare type of growth, usually not cancer, that develops in your adrenal glands, which are located above your kidneys.

What is [18F]mFBG?

It's a special substance with a tiny, safe amount of a radioactive tracer that helps highlight the tumour on a PET-CT scan.

Why is this scan different from a regular CT scan?

This new scan uses the special tracer to try and find the tumour cells more specifically, potentially revealing more tumour areas than a standard CT scan.

Will I become radioactive?

You'll have a very small, safe amount of a radioactive substance for a short time, which quickly leaves your body. The medical team will provide specific safety advice.

What is the purpose of comparing scans to surgery results?

This helps doctors confirm which scan method is better at accurately showing where the tumour is, by matching the scan results to what they find during the operation.