RecruitingOBSERVATIONAL

Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.

This study is about improving how doctors find and treat Cushing's disease, a condition caused by a small growth in the brain (pituitary gland) that makes too much hormone. Currently, MRI scans are used, but they can miss these tiny growths or sometimes show something that isn't really there. Researchers are investigating if a special type of scan called an [18F]FET PET scan can do a better job at pinpointing these growths. The goal is to help surgeons plan operations more effectively and potentially reduce the need for more invasive tests. This study will compare the PET scan results with MRI scans and how patients do after surgery.

At a glance

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

23 Nov 2023

Estimated completion

23 Nov 2028

Cushing Disease ACTH-producing Pituitary Tumour

What is this study about?

Cushing's disease is a condition where a small growth in your pituitary gland (a pea-sized gland at the base of your brain) produces too much of a hormone called ACTH. This extra hormone leads to various health problems. Finding these tiny growths, called microadenomas, is really important for successful treatment, often surgery.

Currently, doctors mainly use MRI scans to locate these growths. However, MRI scans aren't always perfect. They can sometimes miss very small growths (up to 30% of the time) or occasionally show something that looks like a growth but isn't. This can make it tricky for surgeons to know exactly where to operate.

This study is looking into a different type of scan called an [18F]FET PET scan. Researchers believe this PET scan might be better at finding these small ACTH-producing growths than an MRI. If the PET scan is more accurate, it could help doctors plan surgery more precisely, potentially leading to better outcomes for patients and possibly reducing the need for other, more invasive tests.

Key takeaways

Cushing's disease is caused by a tiny growth in the brain's pituitary gland.
Current MRI scans can sometimes miss these small growths.
This study is testing if a special PET scan can find these growths better.
Better detection could help doctors plan surgery more effectively.
Participation involves looking at existing medical scan results and information.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or over. You must have already received a diagnosis of Cushing's disease, confirmed by tests showing high hormone levels. Additionally, you would have already had an MRI scan of your pituitary gland. If a growth was seen on your MRI, it must be smaller than 10 millimetres.

Your case would also need to be something that doctors are actively discussing with a view towards surgery. This study is not for children or teenagers under 18. It also wouldn't be suitable if your growth is very large (called a macroadenoma) or if your high hormone levels are caused by something other than a pituitary growth.

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 Cushing's disease?
Have you had a pituitary MRI scan?
Is your medical team considering surgery for you?
If a growth was seen on MRI, is it smaller than 10 millimetres?

Answer every question to see your result.

What does participation involve?

This study is mainly about looking at existing information and collecting new scan results. If you take part, doctors would look at information from your medical records and your medical scans, particularly your [18F]FET PET scan and your pituitary MRI scan. They would compare the findings from these scans with the results from any surgery you might have had, to see how accurate the scans were at finding the growth. This study does not involve taking new medication or undergoing new treatments beyond what your doctor thinks is best for you. It's a 'data-only' study, meaning researchers are primarily analysing medical images and patient information already collected as part of your care.

Potential risks and benefits

A potential benefit of taking part in this study is contributing to medical knowledge that could improve how Cushing's disease is diagnosed and treated in the future. There are no direct medical benefits to you from participating in this 'data-only' study, as it primarily involves reviewing existing information. The risks are minimal, mainly involving the careful handling of your medical information, which will be kept private. You always have the right to withdraw your consent for your data to be used in the study at any time, without it affecting your medical care.

Locations (1)

Hôpital Louis Pradel - Service de Médecine Nucléaire
Verified postcode
Bron, France· Recruiting

Common questions

What is Cushing's disease?

It's a condition where a small growth in your brain's pituitary gland makes too much of a hormone called ACTH.

What is an MRI scan for?

It's a common scan that uses magnets and radio waves to create detailed pictures inside your body, like your brain.

What is a PET scan?

A PET scan is a special type of imaging test that uses a small amount of a safe, radioactive substance to show how your organs and tissues are working.

Why is this study important?

It aims to find better ways to locate the tiny growths that cause Cushing's disease, which could lead to more successful surgeries.

Will I get new treatment in this study?

No, this study mainly involves looking at your medical scans and information already collected as part of your usual care.

How to find out more

Anthime FLAUS, MD

anthime.flaus@chu-lyon.fr +33 4 72 35 69 99 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.