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Trial record 29 of 105 for:    tendon | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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

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ClinicalTrials.gov Identifier: NCT03287596
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
University Hospital, Bordeaux

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

Condition or disease Intervention/treatment Phase
Spondyloarthropathy Tendinopathy Device: MRI ZTE2 sequence Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI
Actual Study Start Date : April 7, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: HEALTHY VOLUNTEERS
  • 3D sequence ZTE2 DP without gadolinium
  • 3D Sequence UTE without gadolinium
Device: MRI ZTE2 sequence
feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy

Experimental: SPA + NON-SYMPTOMATICS
  • 3D sequence ZTE2 DP without gadolinium
  • 3D Sequence UTE without gadolinium
  • 3D Sequence ZTE2 DP with gadolinium
  • 3D sequence UTE with gadolinium
Device: MRI ZTE2 sequence
feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy

Experimental: SPA + SYMPTOMATICS
  • 3D sequence ZTE2 DP without gadolinium
  • 3D Sequence UTE without gadolinium
  • 3D Sequence ZTE2 DP with gadolinium
  • 3D sequence UTE with gadolinium
Device: MRI ZTE2 sequence
feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy

Experimental: MECHANIC TENDINOPATHY
  • 3D sequence ZTE2 DP without gadolinium
  • 3D Sequence UTE without gadolinium
  • 3D Sequence ZTE2 DP with gadolinium
  • 3D sequence UTE with gadolinium
Device: MRI ZTE2 sequence
feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy




Primary Outcome Measures :
  1. Maximum ZTE signal value in healthy volunteers [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Maximum difference of the ZTE signal value between healthy volunteers and non-symptomatic SpA + patients in the calcaneal fibrocartilage [ Time Frame: baseline ]
  2. Maximum difference of the ZTE signal value between healthy volunteers and symptomatic SpA + patients in the calcaneal fibrocartilage [ Time Frame: baseline ]
  3. Maximum difference in the ZTE signal value between healthy volunteers and patients with mechanical tendinopathy [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287596


Contacts
Contact: Olivier Hauger, MD, Ph.D 335 56 79 56 39 olivier.hauger@chu-bordeaux.fr
Contact: Julie Blanchard 335 57 82 00 00 ext 74560 julie.blanchard@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Olivier Hauger, MD, Ph.D    +335 56 79 56 39    olivier.hauger@chu-bordeaux.fr   
Contact: Julie Blanchard    335 57 82 00 00 ext 74560    julie.blanchard@chu-bordeaux.fr   
Principal Investigator: Olivier Hauger, MD, Ph.D         
Sub-Investigator: Benjamin Dallaudière, MD         
Sub-Investigator: Jean-Thomas Perez, MD         
Sub-Investigator: Claire Fournier, MD         
Sub-Investigator: Thierry Schaeverbeke, MD, Ph.D         
Sub-Investigator: Christophe Richez, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
General Electric
Investigators
Principal Investigator: Olivier Hauger, MD, Ph.D University Hospital, Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03287596     History of Changes
Other Study ID Numbers: CHUBX 2015/16
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Spondylarthropathy
Tendinopathy
MRI
Healthy Volunteer

Additional relevant MeSH terms:
Muscular Diseases
Tendon Injuries
Tendinopathy
Spondylarthropathies
Spondylarthritis
Musculoskeletal Diseases
Wounds and Injuries
Spondylitis
Spinal Diseases
Bone Diseases
Arthritis
Joint Diseases