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CompletedNCT03287596SILENZUpdated Jun 1, 2026

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

An interventional study of MRI ZTE2 sequence in Spondyloarthropathy and Tendinopathy, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Spondyloarthropathy
  • Tendinopathy

Keywords

  • Spondylarthropathy
  • Tendinopathy
  • MRI
  • Healthy Volunteer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    HEALTHY VOLUNTEERS

    * 3D sequence ZTE2 DP without gadolinium * 3D Sequence UTE without gadolinium

    Device: MRI ZTE2 sequence

  • 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

  • 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

  • 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

Interventions

  • DeviceMRI ZTE2 sequence

    feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy

05

What researchers measure

Primary outcomes

  1. Maximum ZTE signal value in healthy volunteers

    Time frame: baseline

Secondary outcomes

  1. Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage

    Time frame: baseline

  2. Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage

    Time frame: baseline

  3. Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy

    Time frame: baseline

06

Study locations

1 site
  • CHU de Bordeaux
    Bordeaux, 33076, France
07

Registry details

Key details

Study ID
NCT03287596
Lead sponsor
University Hospital, Bordeaux
Collaborators
General Electric
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Apr 7, 2018
Primary completion
Jan 21, 2023
Completion
Jan 21, 2023
Last update
Jun 1, 2026

Study contacts

Olivier Hauger, MD, Ph.D
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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