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

Primary Purpose

Spondyloarthropathy, Tendinopathy

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MRI ZTE2 sequence

About this trial

This is an interventional diagnostic trial for Spondyloarthropathy focused on measuring Spondylarthropathy, Tendinopathy, MRI, Healthy Volunteer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

HEALTHY VOLUNTEERS

SPA + NON-SYMPTOMATICS

SPA + SYMPTOMATICS

MECHANIC TENDINOPATHY

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximum ZTE signal value in healthy volunteers

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03287596

First Posted

September 12, 2017

Last Updated

February 21, 2023

Sponsor

University Hospital, Bordeaux

Collaborators

General Electric

1. Study Identification

Unique Protocol Identification Number

NCT03287596

Brief Title

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

Acronym

SILENZ

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

April 7, 2018 (Actual)

Primary Completion Date

January 21, 2023 (Actual)

Study Completion Date

January 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

Collaborators

General Electric

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondyloarthropathy, Tendinopathy

Keywords

Spondylarthropathy, Tendinopathy, MRI, Healthy Volunteer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HEALTHY VOLUNTEERS

Arm Type

Experimental

Arm Description

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

Arm Title

SPA + NON-SYMPTOMATICS

Arm Type

Experimental

Arm Description

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

Arm Title

SPA + SYMPTOMATICS

Arm Type

Experimental

Arm Description

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

Arm Title

MECHANIC TENDINOPATHY

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MRI ZTE2 sequence

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum ZTE signal value in healthy volunteers

Time Frame

baseline

Secondary Outcome Measure Information:

Title

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

Time Frame

baseline

Title

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

Time Frame

baseline

Title

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

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Hauger, MD, Ph.D

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Bordeaux

City

Bordeaux

ZIP/Postal Code

33076

Country

France

12. IPD Sharing Statement

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

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