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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03287596
Acronym
SILENZ
Enrollment
121
Registered
2017-09-19
Start date
2018-04-07
Completion date
2023-01-21
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthropathy, Tendinopathy

Keywords

Spondylarthropathy, Tendinopathy, MRI, Healthy Volunteer

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

Interventions

DEVICEMRI ZTE2 sequence

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER
General Electric
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
Maximum ZTE signal value in healthy volunteersbaseline

Secondary

MeasureTime frame
Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilagebaseline
Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilagebaseline
Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathybaseline

Countries

France

Contacts

PRINCIPAL_INVESTIGATOROlivier Hauger, MD, Ph.D

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026