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Study on Stopping Prednisolone Early in Patients with Negative FDG-PET/CT and Idiopathic Retroperitoneal Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as idiopathic retroperitoneal fibrosis (IRF). This is a rare disease where a fibrous mass forms in the area behind the stomach and intestines, which can cause pain and other symptoms. The treatment being studied in this trial is a medication called prednisone, which is a type of steroid used to reduce inflammation in the body.

The purpose of the study is to understand the effects of stopping steroid treatment early in patients who show no signs of active disease on a special type of scan called FDG-PET/CT. Participants in the study will receive prednisone and will be monitored over a period of time to see if their condition returns after stopping the medication. The study will compare the rate of disease relapse, or return, 12 months after stopping the steroids.

Throughout the study, participants will undergo regular check-ups and imaging tests to monitor their condition. The study will also look at other health factors, such as the occurrence of diabetes, infections, bone fractures, and heart-related events, to ensure a comprehensive understanding of the treatment's impact. The trial aims to provide valuable insights into the management of IRF and the potential benefits of adjusting steroid treatment based on scan results.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria, which include being over 18 years old and having new or untreated relapsing idiopathic retroperitoneal fibrosis (IRF).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the presence of IRF. This involves checking for related symptoms or elevated C-reactive protein (CRP) levels and identifying a retroperitoneal peri-aortic mass on a CT scan.

  3. Step 3

    Medication administration

    The medication prednisolone is administered orally. The dosage and frequency are determined by the study protocol and the patient's specific needs.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment. This includes evaluating the uptake of FDG in PET/CT scans at various intervals: at diagnosis (M0), remission (M9), and at the end of the study (M21).

    Secondary assessments include checking for diabetes, severe infections, osteoporotic fractures, and major cardiovascular events at 12 months after remission.

  5. Step 5

    Discontinuation of steroids

    The main objective is to compare the relapse rate of IRF 12 months after stopping steroid treatment. The decision to discontinue is based on the absence of disease activity as shown in imaging and clinical assessments.

  6. Step 6

    Final evaluation

    The primary endpoint is the cumulative IRF relapse rate at the end of the study (M21). This is determined by a combination of clinical, biological, and radiological criteria.

Who can join the trial?

4 criteria

  • Patient must be over 18 years old.
  • Patient must have a new onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF). This means the condition is either newly diagnosed or has come back after treatment.
  • Patient must have symptoms related to the disease or an elevated CRP level (greater than 20 mg/l). CRP is a substance in the blood that increases when there is inflammation in the body.
  • Patient must have a retroperitoneal peri-aortic mass that surrounds the abdominal vessels, as seen on a CT scan. This means there is a mass in the area behind the stomach and intestines, near the main blood vessel, visible on a special type of X-ray.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Idiopathic Retroperitoneal Fibrosis. This is a condition where there is inflammation and thickening of tissue in the back of the abdomen.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific health criteria set by the study.
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Investigated drugs

Steroids are medications used to reduce inflammation in the body. In this clinical trial, they are being used to treat patients with idiopathic retroperitoneal fibrosis, a condition characterized by the development of excess fibrous tissue in the area behind the stomach and intestines. The study aims to determine if stopping steroid treatment early in patients who show no signs of disease activity on a specific type of imaging test (FDG-PET/CT) affects the rate of disease relapse.

What is already known about the treatment

Prednisone – Prednisone is typically administered orally in the form of tablets. It is a well-established medication in the medical field, frequently referenced in medical literature for its anti-inflammatory and immunosuppressive properties. The main therapeutic indication for prednisone in this context is the treatment of idiopathic retroperitoneal fibrosis. At the molecular level, prednisone works by suppressing the immune system and reducing inflammation through the inhibition of pro-inflammatory cytokines. It is classified pharmacologically as a corticosteroid.

Investigated diseases

Idiopathic Retroperitoneal Fibrosis – This disease is characterized by the development of excess fibrous tissue in the retroperitoneal space, which is the area behind the abdominal cavity. The condition is termed "idiopathic" because its exact cause is unknown. As the fibrous tissue grows, it can encase and compress nearby structures such as the ureters, leading to potential complications like kidney obstruction. Symptoms may include back pain, abdominal pain, and changes in kidney function. The progression of the disease can vary, with some cases remaining stable while others may worsen over time. Monitoring and management are essential to address any complications that arise from the fibrous tissue growth.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514353-30-00Estimated enrolment41 patientsSponsorAssistance Publique Hopitaux De Paris

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