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

May 21, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study

Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

At baseline visit: Eligible patients will be screen during a standard visit care (consultation or hospitalization). A clinical examination, an abdominal CT scan, blood and urine biological tests will be performed.

At inclusion visit: After verification of inclusion and non inclusion criteria, if the patient meets the eligibility criteria, the investigator, will provide the patient with information and details regarding the trial. The consent is obtained and signed after a reflection period of 30 minutes.

The following procedure will be scheduled within 7 days:

  • 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) (pregnancy test if mandatory)
  • Specimens for the biocollection Patients with positive FDG PET/CT (hypermetabolism grade II or III) at M0 will receive oral steroids (prednisone) at 1mg/kg/day during 1 month and then the dose will be tapered to obtain <10mg/day at 6 months and <7,5mg/day at 9 months.

Patients with a negative FDG-PET/CT (hypermetabolism grade 0 or I) at M0 will be excluded of the study.

Follow-up visits : M6, M9,M12,M15,M21, relapse At M6, M12, and M15: During these visits clinical examination (blood pressure measurement, body temperature, heart rate, weight and clinical signs or symptoms related to IRF) will be performed. An abdominal CT scan may be performed as part of the care depending on the clinician's judgment. Glucocorticoid compliance and tapering, concomitant medications and adverse events (including serious cardiovascular adverse events) will be assessed and recorded. A nurse will collect blood and urine.

At M9, M21 or relapse : During these visits clinical examination, an abdominal CT scan, a FDG-PET/CT blood and urine biological tests will be performed.

At M9: The patients who failed to reach remission at M9 are considered as treatment failure and will be treated on best medical judgment by the investigator and excluded to the study. The patients who had a dose of prednisone ≥7,5mg / day at M9 will also be excluded to the study.

Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade 0 or I under a dose of prednisone <7,5mg / day will discontinue steroids treatment.

Patients who achieved remission at M9 and have a retroperitoneal fibrosis visual score grade II or III under a dose of prednisone <7,5mg / day will continue steroids treatment at the actual dose (medical judgment).

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Agen, France, 47000
      • Bordeaux, France, 33604
      • Boulogne-Billancourt, France, 92100
      • Brest, France, 29200
      • Créteil, France, 94000
      • Dijon, France, 21000
      • Lille, France, 59000
        • Active, not recruiting
        • Médecine interne - Lille
      • Marseille, France, 13005
      • Paris, France, 75013
        • Recruiting
        • Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière
        • Contact:
      • Paris, France, 75018
        • Active, not recruiting
        • Néphrologie - Bichat
      • Paris, France, 75018
      • Paris, France, 75014
      • Paris, France, 75012
      • Paris, France, 75015
      • Saint-Denis, France, 93200
        • Active, not recruiting
        • Médecine interne - Delafontaine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years old
  • New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of:
  • Related-disease symptoms (Appendix 17.2) or elevated CRP level (>20 mg/l) AND
  • Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan

Exclusion Criteria:

  • Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),patients with IgG4 disease may be enrolled
  • Contraindication to perform FDG-PET/CT,
  • Contraindication to perform CT scan with injection of contrast agent,
  • Contraindication to treatment by prednisone
  • Active infection
  • Acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial,
  • Active or history of malignancy in last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment,
  • Serum creatinine level greater than 400 µmol/L that cannot be attributed to underlying IRF,
  • Live vaccination received from 4 weeks before inclusion,
  • Inhaled glucocorticoids (except for patients with documented asthma),
  • Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathioprine, mycophenolate mofetil, infliximab, adalimumab, etanercept within the past 3 months,
  • Pregnancy or breastfeeding,
  • Non-affiliation to a social security regime,
  • Subject deprived of freedom, subject under a legal protective measure
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisone
Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.
Drug: Prednisone
Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.
Time Frame: 12 months after discontinuation of steroids

The primary endpoint is the cumulate IRF relapse rate 12 months after discontinuation of steroids.

The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria):

  • Clinical or biological criteria

    • recurrent or new-onset disease related symptoms
    • increase in C-reactive protein (CRP) >20mg/L without other cause
  • And a Radiological criterion o increased of retroperitoneal fibrosis size as compared with the CT scan performed at remission.

The primary endpoint will be centrally adjudicated.
12 months after discontinuation of steroids

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Time Frame: at inclusion
Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III),
at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Time Frame: at inclusion
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at diagnosis (M0)
at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion
Time Frame: at inclusion
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at diagnosis
at inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Time Frame: 9 months after the inclusion
Visual grades of retroperitoneal fibrosis fluorodeoxyglucose uptake as compared to liver fluorodeoxyglucose uptake (which consist of one item that yields a score of 0 to 3) A 0 significate an lack of FDG binding and a 3 an FDG uptake greater than liver uptakesignificate.
9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Time Frame: 9 months after the inclusion
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at remission (M9)
9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)
Time Frame: 9 months after the inclusion
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake remission (M9)
9 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Time Frame: 21 months after the inclusion
Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III)
21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Time Frame: 21 months after the inclusion
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at M21
21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at M21
Time Frame: 21 months after the inclusion
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at M21
21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Time Frame: between inclusion and 21 months after the inclusion
Visual grades of retroperitoneal fibrosis FDG uptake as compared to liver FDG uptake (which consist of one item that yields a score of 0 to III)
between inclusion and 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Time Frame: between inclusion and 21 months after the inclusion
maximal standardized uptake value (SUVmax) within the retroperitoneal fibrosis (regions of interest- ROI) at relapse
between inclusion and 21 months after the inclusion
To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at relapse
Time Frame: between inclusion and 21 months after the inclusion
Metabolic volume (i.e. ratio of metabolically active volume (MAV) to global lesion volume) of retroperitoneal fibrosis FDG uptake at relapse
between inclusion and 21 months after the inclusion
To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,
Time Frame: 21 months after the inclusion
Diagnostic performance of SUVmax for the disease activity
21 months after the inclusion
To assess the performance of hypermetabolism of IRF in FDG-PET/CT for diagnosis of disease activity,
Time Frame: 21 months after the inclusion
Diagnostic performance of MAV (area under the curve (AUC) and performance values for the Youden index) for the disease activity
21 months after the inclusion
To compare at M21 the corticosteroids therapy - related adverse events between patients who continue or discontinue the treatment at M9.
Time Frame: 21 months after the inclusion
Frequency of diabetes, severe infection, osteoporotic fracture and major cardiovascular events 12 months after remission (M21). Serious cardiovascular adverse events are defined as a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death and will be assessed at M12,M15 and M21
21 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Aline DECHANET, Assistance Publique - Hôpitaux de Paris (AP-HP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

November 25, 2028

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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