NCT03287596

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

April 7, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

4.8 years

First QC Date

September 12, 2017

Last Update Submit

February 21, 2023

Conditions

SpondyloarthropathyTendinopathy

Keywords

SpondylarthropathyTendinopathyMRIHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Maximum ZTE signal value in healthy volunteers

    baseline

Secondary Outcomes (3)

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

    baseline

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

    baseline

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

    baseline

Study Arms (4)

HEALTHY VOLUNTEERS

EXPERIMENTAL

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

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

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

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

Device: MRI ZTE2 sequence

Interventions

MRI ZTE2 sequenceDEVICE

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

HEALTHY VOLUNTEERSMECHANIC TENDINOPATHYSPA + NON-SYMPTOMATICSSPA + SYMPTOMATICS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

SpondylarthropathiesTendinopathy

Condition Hierarchy (Ancestors)

SpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesMuscular DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Olivier Hauger, MD, Ph.D

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 19, 2017

Study Start

April 7, 2018

Primary Completion

January 21, 2023

Study Completion

January 21, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

FR(1)