Study on Using [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Patients with Cushing’s Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Cushing’s disease, which is a type of ACTH-dependent hypercortisolism. This condition occurs when the body produces too much of a hormone called cortisol, often due to a small tumor in the pituitary gland. The study will use a special imaging technique called [18F]FET PET-MRI to help detect these tumors more accurately. The treatment involves using a solution for injection that contains a substance called fluoroethyltyrosine F-18, which helps in creating detailed images of the pituitary gland.

The purpose of the study is to see if the [18F]FET PET-MRI method can better identify Cushing’s disease compared to the current standard method, which is a procedure called IPSS (Inferior Petrosal Sinus Sampling). Participants in the study will undergo imaging with the [18F]FET PET-MRI to see if it can correctly differentiate between Cushing’s disease and another condition called ectopic Cushing’s syndrome, where the excess cortisol is produced by tumors located outside the pituitary gland.

Throughout the study, participants will receive the fluoroethyltyrosine F-18 injection and undergo the PET-MRI scan. The results will be compared to those from the IPSS procedure to determine which method is more effective in identifying the source of the excess hormone production. The study aims to improve the accuracy of diagnosing Cushing’s disease, potentially leading to better treatment options for patients with this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the study will be confirmed based on specific criteria, such as age and certain medical conditions related to ACTH-dependent hypercortisolism.

You will undergo a series of tests to confirm your condition, including hormone level assessments and imaging tests if necessary.

2 preparation for imaging

Before the imaging procedure, you will receive detailed instructions on how to prepare. This may include fasting or avoiding certain medications for a specified period.

You will be informed about the procedure and what to expect during the imaging session.

3 imaging procedure

You will undergo an imaging procedure called [18F]FET PET-MRI. This involves receiving an injection of a solution called FET through a vein in your arm.

The imaging will help in detecting pituitary adenomas, which are small tumors in the pituitary gland, associated with Cushing’s disease.

4 post-imaging follow-up

After the imaging procedure, you will have a follow-up appointment to discuss the results with your healthcare provider.

The results will help determine if Cushing’s disease is correctly differentiated from other conditions, such as ectopic Cushing’s syndrome.

5 ongoing monitoring

Throughout the study, you may be required to attend additional follow-up visits to monitor your condition and any changes in your health.

These visits will ensure that the study’s objectives are met and that your health is closely observed.

Who Can Join the Study?

Must be at least 18 years old.
Must have a confirmed diagnosis of ACTH-dependent hypercortisolism. This means:
- High levels of a hormone called ACTH in the blood.
- At least two of the following:
  - A test called the overnight 1mg dexamethasone suppression test shows a result greater than 50 nmol/L.
  - High levels of cortisol in saliva late at night, confirmed by at least two out of three tests.
  - High levels of cortisol in urine collected over 24 hours, confirmed by at least two tests.
Must have a pituitary microadenoma (a small growth in the pituitary gland less than 10mm) or unclear results from a standard MRI scan of the pituitary gland area.
Must need further evaluation with a procedure called IPSS (Inferior Petrosal Sinus Sampling).

Who Cannot Join the Study?

Patients who do not have ACTH-dependent hypercortisolism cannot participate. This is a condition where the body produces too much of a hormone called cortisol due to a problem with the pituitary gland or other sources.
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 be at higher risk of harm or exploitation.

Where you can join this trial?

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Site Name	City	Country	Status
Eoimlhm Uhoeyeoeuiww Mzgmsrf Crzwwoe Rsxgufyak (lmhrmgj Mcf	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	02.06.2025

Trial locations

Investigated drugs:

Fluoroethyltyrosine F-18

[18F]FET PET-MRI is a special type of imaging test that combines two techniques: PET and MRI. PET stands for Positron Emission Tomography, and MRI stands for Magnetic Resonance Imaging. This test uses a small amount of a radioactive substance called [18F]FET to help doctors see detailed images of the pituitary gland in the brain. The goal is to find and identify pituitary adenomas, which are small tumors that can cause Cushing’s disease. By using this imaging test, doctors hope to better distinguish between Cushing’s disease and other similar conditions, helping to ensure that patients receive the correct diagnosis and treatment.

Investigated diseases:

Hyperadrenocorticism

ACTH-dependent hypercortisolism – This condition is characterized by excessive production of adrenocorticotropic hormone (ACTH), which leads to an overproduction of cortisol by the adrenal glands. It can result from a pituitary adenoma, known as Cushing’s disease, or from ectopic production of ACTH by non-pituitary tumors, referred to as ectopic Cushing’s syndrome. The excess cortisol causes symptoms such as weight gain, high blood pressure, and changes in skin appearance. Over time, it can lead to complications like muscle weakness and bone loss. The progression of the disease depends on the underlying cause and the level of cortisol excess. Identifying the source of ACTH overproduction is crucial for understanding the disease’s progression.

Trial ID:

2024-518908-46-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Using [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Patients with Cushing’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?