AuthorisedTherapeutic confirmatory (Phase III)Interventional

Use of [18F]FET PET-MRI to improve detection of pituitary adenomas in Cushing’s disease

This research study is looking into a new scanning method called FET PET-MRI. It's designed for people who have a condition where their body produces too much cortisol, often due to a problem with the pituitary gland. This condition is called Cushing's disease. There are other similar conditions where too much cortisol is made elsewhere in the body. The main goal is to see if this new FET PET-MRI scan is better than the test currently used (called IPSS) at working out if the problem is in the pituitary gland or somewhere else. By improving how doctors pinpoint the exact cause, this study aims to help patients get the right treatment more quickly and effectively. We're comparing the new scan to the existing one to see if it works just as well, or even better, at identifying where the high cortisol is coming from.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

15 May 2025

ACTH-dependent hypercortisolism

What is this study about?

This study is investigating a new way to help doctors find out why some people have too much of a hormone called cortisol in their bodies. High cortisol can cause a condition called Cushing's syndrome. In many cases, this is caused by a small growth in a gland at the base of the brain, called the pituitary gland. This specific problem is known as Cushing's disease.

However, sometimes high cortisol can be caused by a problem elsewhere in the body. It's really important for doctors to know exactly where the problem is coming from to make sure you get the correct treatment. Currently, doctors use a test called IPSS to help figure this out. This study is testing a new type of scan called FET PET-MRI to see if it can do an even better job.

The main aim of this research is to see if the FET PET-MRI scan is as good as, or better than, the current standard test (IPSS) at correctly identifying if the problem causing high cortisol is in the pituitary gland. If this new scan proves to be more accurate, it could mean doctors can diagnose and treat people with Cushing's disease more effectively in the future.

Key takeaways

The study is testing a new scan (FET PET-MRI) for Cushing's disease.
It aims to find out if the new scan is better at pinpointing the cause of high cortisol.
This could lead to more accurate diagnosis and treatment.
The new scan is being compared to the current standard test (IPSS).
It's for adults aged 18 and over with high ACTH and cortisol levels.
Participating may involve additional scans and hospital visits.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or over. This study is open to both men and women.

The main requirement is that you have a condition where your body is making too much of a hormone called ACTH, which then leads to too much cortisol (often called ACTH-dependent hypercortisolism). This means the study is focused on people who have been diagnosed with, or are suspected of having, Cushing's disease or a similar condition where the body is overproducing cortisol because of high ACTH levels.

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 told your body is producing too much ACTH and cortisol?
Are you considering, or are you being investigated for, Cushing's disease?
Are you able to undergo PET and MRI scans?

Answer every question to see your result.

What does participation involve?

The detailed involvement for participants isn't fully described in the summary provided. However, generally in studies like this, if you participate, you would likely undergo the new FET PET-MRI scan. This scan combines two types of imaging: a PET scan, which uses a small amount of a radioactive substance (in this case, labelled FET) to show how your cells are working, and an MRI scan, which uses strong magnets and radio waves to create detailed pictures of your organs and tissues. You would also likely undergo the standard IPSS test, as the study aims to compare the two methods. You might have several visits for assessments, scans, and possibly blood tests. If you have surgery as part of your treatment, the study would also collect information from that to assess the new scan's accuracy. The total duration of your participation would depend on the study's design and your treatment plan, but it's common for such studies to involve checks before and after treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the new FET PET-MRI scan might help doctors diagnose your condition more accurately, which could lead to better treatment outcomes in the future, not just for you but for others. While the exact risks of FET PET-MRI aren't detailed here, PET scans involve a very small amount of radiation, and MRI scans are generally safe but can be noisy and claustrophobic for some. All medical scans have potential side effects or discomforts. You will be given a full explanation of these risks before deciding to take part, and you have the right 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 Cushing's disease?

Cushing's disease is a condition where your body makes too much of a hormone called cortisol, usually due to a small growth in your pituitary gland.

What is FET PET-MRI?

It's a new type of medical scan that combines two powerful imaging methods to get very detailed pictures and information about your body, especially to find out where the problem causing high cortisol might be.

What is IPSS?

IPSS is the standard test currently used by doctors to help figure out if high cortisol is coming from the pituitary gland or somewhere else in the body.

Will taking part in this study help me directly?

While the main goal is to improve diagnosis for future patients, your participation will provide valuable information that could lead to better care for people with Cushing's disease.

Will I have to pay to join the study?

No, you will not have to pay to participate in a clinical trial. All study-related tests and procedures are typically covered by the research study itself.