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

• Sponsor: Ramsay Générale de Santé (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05593068
• Collaborator: European Clinical Trial Experts Network (Other)
• Enrollment: 185
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 18.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deposition; Dialysis; Iatrogenic Hemosiderosis	Procedure: MRI

Study Design

• Study Type: Observational
• Anticipated Enrollment: 185 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; Pancreatic MRI

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé Claude Galien	Quincy-sous-Sénart		France	91480

Sponsors and Collaborators

• Ramsay Générale de Santé
• European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ramsay Générale de Santé
• ClinicalTrials.gov Identifier: NCT05593068
• Other Study ID Numbers: ERDFP
• First Posted: Oct 25, 2022
• Last Update Posted: Oct 25, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemochromatosis; Hemosiderosis

Study Results

No Results Posted as of Oct 25, 2022