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

NCT05150353 | Unknown

• 1 other identifier: 2018-A00881-54 Promoteur
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyloid; Systemic Amyloidosis

Outcome Measures

Primary Outcomes (1)

• T1 measurement (ms) associated with each of the 5 regions of interest at the wrist

  1 day

Study Arms (2)

Patients with cardiac amyloidosis

EXPERIMENTAL

Procedure: MRI

Healthy volunteers

PLACEBO COMPARATOR

Procedure: MRI

Interventions

MRI PROCEDURE

Wrist MRI

Healthy volunteers; Patients with cardiac amyloidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: January 24, 2020
• Primary Completion: October 24, 2021
• Study Completion: April 24, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

FR (1)