SpondyloarthropathySILENZNCT03287596
Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at 3T MRI
A study testing MRI ZTE2 sequence in people with Spondyloarthropathy and Tendinopathy, run by University Hospital, Bordeaux at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthropathy, Tendinopathy
- What is being tested?
- MRI ZTE2 sequence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2018to 21 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years,
- Covered under social security
- Informed signed consent
- Additional criteria for each group:
- GROUP 1: HEALTHY VOLUNTEERS
- Absence of diagnosis of spondyloarthropathies
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- 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.
Who cannot join
- Age less than 18 yrs old
- Pregnant or lactating woman
- History or presence coronary pathology
- Septic arthritis
- Immunodeficiency.
- Contra-indication for MRI exam
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- Legal protection
- Additional criteria for GROUPS 2, 3 and 4:
- History or presence of renal insufficiency
- Allergy to macrocyclic gadolinium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Spondyloarthropathy, Tendinopathy
- Being tested
- MRI ZTE2 sequence
- Keywords
- Spondylarthropathy, Tendinopathy, MRI, Healthy Volunteer
- Medical subject headings
- Spondylarthropathies, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ZTE2 sequenceDevice
feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy
| Study group | Role | What they receive |
|---|---|---|
| HEALTHY VOLUNTEERS | Experimental | * 3D sequence ZTE2 DP without gadolinium
* 3D Sequence UTE without gadolinium Receives: Device: MRI ZTE2 sequence |
| SPA + NON-SYMPTOMATICS | Experimental | * 3D sequence ZTE2 DP without gadolinium
* 3D Sequence UTE without gadolinium
* 3D Sequence ZTE2 DP with gadolinium
* 3D sequence UTE with gadolinium Receives: Device: MRI ZTE2 sequence |
| SPA + SYMPTOMATICS | Experimental | * 3D sequence ZTE2 DP without gadolinium
* 3D Sequence UTE without gadolinium
* 3D Sequence ZTE2 DP with gadolinium
* 3D sequence UTE with gadolinium Receives: Device: MRI ZTE2 sequence |
| MECHANIC TENDINOPATHY | Experimental | * 3D sequence ZTE2 DP without gadolinium
* 3D Sequence UTE without gadolinium
* 3D Sequence ZTE2 DP with gadolinium
* 3D sequence UTE with gadolinium Receives: Device: MRI ZTE2 sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum ZTE signal value in healthy volunteers
Measured: baseline
Secondary outcomes (3)
Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage
Measured: baseline
Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage
Measured: baseline
Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start7 Apr 2018
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
- Investigators
- Olivier Hauger, MD, Ph.D, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287596
- Sponsor's protocol ID
- CHUBX 2015/16
- Other IDs
- 2017-A01543-50
- Acronym
- SILENZ
- Status last verified
- Feb 2023
- First submitted
- 12 Sep 2017
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI
- ClinicalTrials.gov ID
- NCT03287596
- Acronym / sponsor ID
- SILENZ / CHUBX 2015/16
- Conditions
- Spondyloarthropathy, Tendinopathy
- Keywords
- Spondylarthropathy, Tendinopathy, MRI, Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HEALTHY VOLUNTEERS | Experimental | Device: MRI ZTE2 sequence* 3D sequence ZTE2 DP without gadolinium * 3D Sequence UTE without gadolinium |
| SPA + NON-SYMPTOMATICS | Experimental | Device: MRI ZTE2 sequence* 3D sequence ZTE2 DP without gadolinium * 3D Sequence UTE without gadolinium * 3D Sequence ZTE2 DP with gadolinium * 3D sequence UTE with gadolinium |
| SPA + SYMPTOMATICS | Experimental | Device: MRI ZTE2 sequence* 3D sequence ZTE2 DP without gadolinium * 3D Sequence UTE without gadolinium * 3D Sequence ZTE2 DP with gadolinium * 3D sequence UTE with gadolinium |
| MECHANIC TENDINOPATHY | Experimental | Device: MRI ZTE2 sequence* 3D sequence ZTE2 DP without gadolinium * 3D Sequence UTE without gadolinium * 3D Sequence ZTE2 DP with gadolinium * 3D sequence UTE with gadolinium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥18 years,
- Covered under social security
- Informed signed consent
- GROUP 1: HEALTHY VOLUNTEERS
- Absence of diagnosis of spondyloarthropathies
Key exclusion criteria (10 listed)
- Age less than 18 yrs old
- Pregnant or lactating woman
- History or presence coronary pathology
- Septic arthritis
- Immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ZTE2 sequencefeasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy | Device | HEALTHY VOLUNTEERS, MECHANIC TENDINOPATHY, SPA + NON-SYMPTOMATICS, SPA + SYMPTOMATICS |
Primary outcome
Maximum ZTE signal value in healthy volunteers
Time frame: baseline
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Hauger, MD, Ph.D principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI ZTE2 sequence in people with Spondyloarthropathy and Tendinopathy, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum ZTE signal value in healthy volunteers (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.