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

Not yet recruiting

• Conditions: Iron Deposition; Iatrogenic Hemosiderosis; Dialysis
• Interventions: Procedure: MRI

• Registration Number: NCT05593068
• Lead Sponsor: Ramsay Générale de Santé

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-25
• Last Update Posted: 2022-10-25
• Study Start: 2022-11-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dialysed patients with suspicion of hepatic iron	MRI	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.

Primary Outcome Measures

Name	Time	Method
Presence of pancreatic iron deposit	1 day	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.

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France