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

Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI

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

Study Overview

• Status: Completed
• Conditions: Tendinopathy; Spondyloarthropathy
• Intervention / Treatment: Device: MRI ZTE2 sequence

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

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Chu de Bordeaux

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEALTHY VOLUNTEERS; 3D sequence ZTE2 DP without gadolinium; 3D Sequence UTE without gadolinium	Device: MRI ZTE2 sequence; feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy
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	Device: MRI ZTE2 sequence; feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy
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	Device: MRI ZTE2 sequence; feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy
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	Device: MRI ZTE2 sequence; feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum ZTE signal value in healthy volunteers	baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: General Electric
• Investigators: Principal Investigator: Olivier Hauger, MD, Ph.D, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2018
• Primary Completion (Actual): January 21, 2023
• Study Completion (Actual): January 21, 2023

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Healthy Volunteer; Tendinopathy; Spondylarthropathy
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Spinal Diseases; Tendon Injuries; Spondylarthritis; Spondylitis; Spondylarthropathies; Tendinopathy
• Other Study ID Numbers: CHUBX 2015/16; 2017-A01543-50 (Other Identifier: ANSM)

Drug and device information, study documents

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