Ongoing Clinical Trials for Retroperitoneal Fibrosis
Currently, there is 1 ongoing clinical trial investigating treatment approaches for retroperitoneal fibrosis. This trial is taking place in France and focuses on optimizing steroid treatment duration based on imaging results in patients with the idiopathic form of this rare condition.
Clinical trial locations
Study on Stopping Prednisolone Early in Patients with Negative FDG-PET/CT and Idiopathic Retroperitoneal Fibrosis
This clinical trial is being conducted in France to study whether patients with idiopathic retroperitoneal fibrosis can safely stop steroid treatment earlier than usual if their imaging scans show no signs of active disease.
Main inclusion criteria:
- Adults over 18 years of age
- Newly diagnosed or relapsing idiopathic retroperitoneal fibrosis that has not yet been treated
- Presence of symptoms related to the condition or elevated levels of C-reactive protein (CRP) in the blood, indicating inflammation (greater than 20 mg/l)
- Evidence of a mass in the area behind the abdominal organs, near the major blood vessels, visible on CT scan
Main exclusion criteria:
- Diagnosis other than idiopathic retroperitoneal fibrosis
- Age outside the specified range for the study
- Belonging to a vulnerable population requiring special protection
- Not meeting other specific health criteria defined by the study protocol
Focus and goal:
The trial aims to understand whether stopping steroid treatment early is safe and effective for patients whose FDG-PET/CT scans show no signs of active disease. The main goal is to compare the rate of disease relapse 12 months after stopping steroids. Participants will undergo regular monitoring through clinical assessments and imaging tests at specific intervals: at diagnosis, at 9 months when remission is achieved, and at 21 months at the study’s end. The study will also track other important health outcomes, including the occurrence of diabetes, severe infections, bone fractures, and cardiovascular events to ensure a comprehensive understanding of the treatment’s impact.
Investigational drug:
The medication being studied is prednisolone, a steroid that reduces inflammation in the body. Steroids like prednisolone are commonly used to treat idiopathic retroperitoneal fibrosis by suppressing the immune system and reducing the inflammation that causes fibrous tissue to form. The study specifically investigates whether treatment can be shortened in patients who respond well to therapy, as confirmed by specialized imaging scans.
Summary
Currently, only one clinical trial is actively recruiting patients with retroperitoneal fibrosis. This French study represents an important effort to personalize treatment for this rare condition by using advanced imaging techniques to guide decisions about treatment duration. The focus on prednisolone reflects the standard care approach for this disease, while the investigation into early treatment discontinuation addresses an important clinical question: how to minimize steroid exposure and its side effects while maintaining disease control. Patients interested in participating should discuss eligibility with their healthcare providers, particularly if they have newly diagnosed or relapsing idiopathic retroperitoneal fibrosis.