Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis (AMYLOCARP) (AMYLOCARP)

Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis

This study is based on the hypothesis that MRI could make it possible to non-invasively detect these amyloid deposits at the level of the wrist using parametric sequences known as T1 mapping, in the form of an extension of T1 in the wrists. areas where amyloid deposits are found in the wrist.

Study Overview

• Status: Recruiting
• Conditions: Amyloid; Systemic Amyloidosis
• Intervention / Treatment: Procedure: MRI

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Champigny-sur-Marne, France, 94500
    • Recruiting
    • Hôpital Privé Paul d'Egine
    • Contact: Ruxandra COSSON-STANESCU, Dr; Phone Number: 0612247248; Email: ruxandra.cosson@wanadoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patient group:

• Woman or man over 18 years old
• With ATTR or AL cardiac amyloidosis with or without carpal tunnel. The diagnosis of amyloidosis must be proven by a positive myocardial biopsy or diphosphonate scintigraphy.
• Affiliate or beneficiarie of a social security scheme.
• Having signed the free and informed consent.

Healthy volunteers:

• Woman or man over 18 years old
• Affiliate or beneficiarie of a social security scheme.
• Having signed the free and informed consent.

Exclusion Criteria:

Patient group:

• Patients participating in another clinical study.
• Patients suffering from rheumatoid arthritis or other autoimmune disease (vasculitis, lupus, scleroderma, etc.)
• Patients with a medical history of wrist surgery (exclude the operated side).
• Patients with a contraindication to performing an MRI (pacemaker, etc.)
• Pregnant or breastfeeding women.
• Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision.

Healthy volunteer:

• Volunteers participating in another clinical study.
• Volunteers suffering from rheumatoid arthritis or other autoimmune disease (vasculitis, lupus, scleroderma, etc.)
• Pregnant or breastfeeding women.
• Volunteer with a contraindication to performing an MRI (pacemaker, etc.)
• Protected volunteers: Adults under guardianship, guardianship or other legal protection, deprived of their liberty by judicial or administrative decision.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Healthy volunteers	Procedure: MRI; Wrist MRI
Experimental: Patients with cardiac amyloidosis	Procedure: MRI; Wrist MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
T1 measurement (ms) associated with each of the 5 regions of interest at the wrist	1 day

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): October 24, 2021
• Study Completion (Anticipated): April 24, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Pathological Conditions, Anatomical; Proteostasis Deficiencies; Amyloidosis; Plaque, Amyloid
• Other Study ID Numbers: 2018-A00881-54 Promoteur

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No