RecruitingPHASE4INTERVENTIONAL

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis

This study is for adults with a rare condition called idiopathic retroperitoneal fibrosis (IRF), where extra tissue grows behind your tummy organs. We're looking at how best to give a steroid medicine called prednisone. Some patients with IRF respond well to prednisone. Before treatment, patients will have a special scan called a PET/CT. If this scan shows a low level of disease activity, we want to see if they can take prednisone for a shorter time than usual. This study will follow patients for up to 21 months to check if this approach is safe and helps to manage their condition. The aim is to find ways to reduce the amount of time patients need to take strong medications.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

25 Nov 2022

Estimated completion

25 Nov 2028

Idiopathic Retroperitoneal Fibrosis

What is this study about?

This study is exploring a rare condition called idiopathic retroperitoneal fibrosis (IRF). This is when extra tissue grows behind the organs in your tummy, which can sometimes cause problems. The study focuses on adults who have IRF and have not been treated before, or whose condition has returned. The main medicine we are looking at is a steroid called prednisone, which is often used to treat IRF.

Traditionally, patients with IRF might take prednisone for a long time. However, we're trying to find out if some patients, particularly those whose initial scans show a lower level of disease activity, could benefit from a shorter course of treatment. The study uses a special scan called a FDG-PET/CT, which helps doctors see how active the disease is. If this scan shows a low level of activity at the start, we want to see if reducing the steroid treatment is still effective.

By carefully following patients, this study hopes to understand if stopping prednisone earlier for certain individuals is safe and helps to manage their IRF just as well, without increasing the risk of the condition coming back. This could mean fewer side effects for patients from taking powerful medicines for a long time. The overall goal is to improve how we treat IRF and make life better for those living with the condition.

Key takeaways

This study investigates a shorter steroid treatment for specific IRF patients.
It uses a special scan (FDG-PET/CT) to guide treatment decisions.
Patients will take prednisone, with the dose gradually decreasing.
Close monitoring over 21 months by doctors and nurses.
Aims to reduce long-term side effects of medication.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult (over 18 years old) with a new diagnosis of idiopathic retroperitoneal fibrosis (IRF), or your IRF has returned and hasn't been treated yet. We'll be looking for specific signs of IRF, such as symptoms like pain or certain blood test results, along with a scan showing the extra tissue around your tummy area.

However, there are reasons why you might not be able to join. For example, if your IRF is caused by something else, like another illness or a medicine you're taking, then this study isn't suitable. We also can't include you if you've had certain serious illnesses recently, like particular infections or cancers, or if you're pregnant or breastfeeding. There are also specific medical conditions and medicines that mean you wouldn't be able to take part because they might interfere with the study or make the treatment unsafe for you.

We'll check carefully during your first visits to make sure the study is a good fit for you and that it's safe for you to take part. It's important that you understand why we ask all these questions.

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 over 18 years old?
Do you have new or returning idiopathic retroperitoneal fibrosis (IRF)?
Have you not received treatment for your IRF recently?
Are you able to have CT and PET/CT scans?
Are you not pregnant or breastfeeding?
Do you not have other serious medical conditions or treatments that could interfere?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your journey would start with a detailed check-up. This includes a physical exam, a CT scan of your tummy, and blood and urine tests. Once confirmed you can join, you'll have a special discussion with the study team to answer all your questions, and you'll have at least 30 minutes to think about it before signing any consent forms.

Within a week, you'll have an FDG-PET/CT scan (and a pregnancy test if needed) and some samples collected for further analysis. During the study, you'll take prednisone medicine, starting at a specific dose which would then be slowly reduced over several months. You'll have regular follow-up visits over a total of 21 months. Some visits (at 6, 12, and 15 months) will involve physical checks, assessing your medicines, and blood/urine tests. Other visits (at 9 and 21 months, or if your condition comes back) will include more detailed checks like a CT scan and another FDG-PET/CT scan, as well as the usual blood and urine tests. If the treatment isn't working at 9 months, you might leave the study to receive other care.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as very close monitoring of your health by a specialist team and access to treatments under carefully controlled conditions. We are hoping to find out if a shorter course of prednisone could reduce side effects for some patients. However, there are potential risks, as with any medical treatment. Prednisone can have side effects, and while we'll be carefully monitoring you, there's always a chance of unexpected effects or that the treatment might not work as well for you as we hoped. Having several scans and blood tests are also part of the study. You're free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Médecine Interne
Verified postcode
Agen, France· Recruiting
Médecine interne
Verified postcode
Brest, France· Recruiting
Médecine interne et maladies infectieuses - GH Sud Haut Lévêque
Verified postcode
Bordeaux, France· Recruiting
Médecine interne - Ambroise Paré
Verified postcode
Boulogne-Billancourt, France· Recruiting
Médecine interne - Henri-Mondor
Verified postcode
Créteil, France· Recruiting
Médecine interne et immunologie clinique - Dijon
Verified postcode
Dijon, France· Recruiting
Médecine interne - Lille
Verified postcode
Lille, France· Active not recruiting
Médecine Interne - La Timone
Verified postcode
Marseille, France· Recruiting
Médecine interne - Saint Antoine
Verified postcode
Paris, France· Recruiting
Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière
Verified postcode
Paris, France· Recruiting
Médecine interne - Cochin
Verified postcode
Paris, France· Recruiting
Médecine vasculaire - HEGP
Verified postcode
Paris, France· Recruiting

Common questions

What is idiopathic retroperitoneal fibrosis (IRF)?

IRF is a rare condition where extra tissue grows behind your tummy organs, which can sometimes cause problems. 'Idiopathic' means we don't know the exact cause.

What is FDG-PET/CT?

It's a special type of scan that helps doctors see how active the disease is in your body by looking at how your cells are using sugar.

What is prednisone?

Prednisone is a steroid medicine commonly used to reduce inflammation and help manage conditions like IRF. It's a powerful medicine.

How long will I be in the study?

The study will follow you for up to 21 months, with regular check-up and scan visits throughout this time.

Can I leave the study early?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your usual medical care.

How to find out more

Karim SACRE

karim.sacre@aphp.fr 01.40.25.60.19 Official trial record

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