Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at 3T MRI

Overview

The purpose of this study is to accurately map calcaneal fibrocartilage using TE = 0 ms imaging, and then apply measurements of our control population to SpA patients with peripheral enthesis study using the calcaneal tendon as a clinical model

Full Title of Study: “Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 21, 2023

Detailed Description

The human body contains a lot of tissue components with short T2 (transversal relaxation time) that are not or only poorly detected on conventional T2-weighted MR sequences. These components are mostly located in musculoskeletal organs such as tendons, ligaments, menisci, periosteum or cortical bone. Considering that conventional sequences do not detect tissue components with T2 shorter than 10ms, imaging of body tendon or enthesis is therefore very limited. This represents a limitation of MR imaging in early diagnosis of a certain number of pathologies, such as mechanical or mostly inflammatory tendinopathy or enthesopathy. This study, would provide the feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy Achilles tendon enthesis at 3 T, and would demonstrate that this sequence allows the detection of SpA enthesopathy prior to conventional sequences and enables disease monitoring. For those purposes, during inclusion visit sequences ZTE 2 and UTE (with and without gadolinium injection) will be add to routine macrocyclic gadolinium injected MRI of 3 groups of patients (symptomatic and non sympatomatic spondyloarthropathy and mechanical tendinopathy). Healthy volunteer group will undergo an MRI exam without gadolinium injection comprised of following sequences T2 FS, T1, DP FS, ZTE 2 and UTE. No follow up visit are schedule in this study

Interventions

  • Device: MRI ZTE2 sequence
    • feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy

Arms, Groups and Cohorts

  • Experimental: HEALTHY VOLUNTEERS
    • 3D sequence ZTE2 DP without gadolinium 3D Sequence UTE without gadolinium
  • Experimental: SPA + NON-SYMPTOMATICS
    • 3D sequence ZTE2 DP without gadolinium 3D Sequence UTE without gadolinium 3D Sequence ZTE2 DP with gadolinium 3D sequence UTE with gadolinium
  • Experimental: SPA + SYMPTOMATICS
    • 3D sequence ZTE2 DP without gadolinium 3D Sequence UTE without gadolinium 3D Sequence ZTE2 DP with gadolinium 3D sequence UTE with gadolinium
  • Experimental: MECHANIC TENDINOPATHY
    • 3D sequence ZTE2 DP without gadolinium 3D Sequence UTE without gadolinium 3D Sequence ZTE2 DP with gadolinium 3D sequence UTE with gadolinium

Clinical Trial Outcome Measures

Primary Measures

  • Maximum ZTE signal value in healthy volunteers
    • Time Frame: baseline

Secondary Measures

  • Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage
    • Time Frame: baseline
  • Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage
    • Time Frame: baseline
  • Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy
    • Time Frame: baseline

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 years, – Covered under social security – Informed signed consent Additional criteria for each group: GROUP 1: HEALTHY VOLUNTEERS – Absence of diagnosis of spondyloarthropathies – No previous history of plantar support and pain, calcaneal tendinopathy, infiltration or surgery GROUP 2: SPA + NON-SYMPTOMATICS AT THE CALCANEEN FIBROCARTILAGE LEVEL – ASAS criteria axial or appendicular – No previous history of plantar support and pain, infiltration or surgery – Prescription Achile's tendon MRI with injection of contrast agent (macrocyclic gadolinium) in usual care. GROUP 3: SPA + SYMPTOMATICS AT THE CALCANEEN FIBROCARTILAGE LEVEL – ASAS criteria axial or appendicular – Clinical suspicion of rheumatic enthesopathy – Absence of a history of calcaneal infiltration or surgery – Prescription Achile's tendon MRI with injection of contrast agent (macrocyclic gadolinium) in usual care. GROUP 4: MECHANIC TENDINOPATHY – Clinical diagnosis of calcaneal mechanical tendinopathy – Absence of diagnosis of spondyloarthropathies – No any previous history of plantar support disorder, calcaneal infiltration or surgery – Prescription Achile's tendon MRI with injection of contrast agent (macrocyclic gadolinium) in usual care. Exclusion Criteria:

  • Age less than 18 yrs old – Pregnant or lactating woman – History or presence coronary pathology – Septic arthritis – Immunodeficiency. – Contra-indication for MRI exam – Legal protection Additional criteria for GROUPS 2, 3 and 4: – History or presence of renal insufficiency – Allergy to macrocyclic gadolinium

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Bordeaux
  • Collaborator
    • General Electric
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Olivier Hauger, MD, Ph.D, Principal Investigator, University Hospital, Bordeaux

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.