Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)

NCT05593068 | Unknown

• 1 other identifier: ERDFP
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits. In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2\* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.

Conditions

Iron Deposition; Dialysis; Iatrogenic Hemosiderosis

Outcome Measures

Primary Outcomes (1)

• Presence of pancreatic iron deposit

  Presence of pancreatic iron deposits as a function of hepatic iron level during iron overload in the dialysis patient will be evaluated from the pancreatic iron concentration measured by MRI and expressed by a T2\* value in ms.

  1 day

Study Arms (1)

Dialysed patients with suspicion of hepatic iron

Patients on dialysis at Claude Galien Private Hospital who had one or more MRI scans to monitor possible hepatic iron overload between May 2012 and March 2018.

Procedure: MRI

Interventions

MRI PROCEDURE

Pancreatic MRI

Dialysed patients with suspicion of hepatic iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient on hemodialysis or peritoneal dialysis at Claude Galien Private Hospital. They had to perform an MRI for iron quantification

You may qualify if:

• Male, female, over 18 years old
• Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital
• Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification
• Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study

You may not qualify if:

• Patient who has signed a form to object to the use of their health data
• Pregnant woman
• Poor adherence to the dialytic technique
• Severe cognitive impairment
• Hepatic cirrhosis
• Frank inflammatory syndrome or an active infectious disease
• Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases
• Recent major bleeding (\< 3 months)
• Recent major surgery (\< 3 months)
• Transfusion dependence
• Progressive malignant disease
• Pacemakers incompatible with an MRI and metal heart valves

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Related Publications (1)

• Rostoker G, Griuncelli M, Francisco S, Loridon C, Languille-Llitjos E, Boulahia G, Cohen Y. Evidence of pancreatic iron deposits and their association with mortality in dialysis-associated iatrogenic hemosiderosis. Clin Kidney J. 2025 Oct 6;18(11):sfaf309. doi: 10.1093/ckj/sfaf309. eCollection 2025 Nov.

  PMID: 41215782 DERIVED

MeSH Terms

Conditions

Siderosis

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jeanfrancois.oudet@free.fr

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

FR (1)