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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
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

Experimental

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

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

First Posted
September 12, 2017
Last Updated
February 21, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
General Electric
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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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