Clinical trial NCT03287596: Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at 3T MRI
Official title: Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthropathy
Tendinopathy
Keywords: Spondylarthropathy
Tendinopathy
MRI
Healthy Volunteer
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2017-09-19
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Maximum ZTE signal value in healthy volunteers
timeFrame: baseline
Secondary outcomes:
measure: Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage
timeFrame: baseline
measure: Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage
timeFrame: baseline
measure: Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy
timeFrame: baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Olivier Hauger, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: