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

Dialysis Clinical Trial

— ERDFP  

Official title:

Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05593068
• Other study ID #: ERDFP
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2022
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jeanfrancois.oudet[@]free.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 185
• Est. completion date: September 1, 2023
• Est. primary completion date: April 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Hemochromatosis
• Hemosiderosis

Intervention

Procedure:
• MRI
Pancreatic MRI

Locations

Country	Name	City	State
France	Hôpital Privé Claude Galien	Quincy-sous-Sénart

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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