NCT02792010

Brief Summary

Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage modifications could provide better patient treatment. The T1rho MRI sequence allows the quantification of the cartilage signal that is correlated to modifications of the cartilage matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the measurements. T1rho and T2 mapping sequences were acquired twice during the same session with 30 minutes interval to see if values were modified after a 30 minutes delay in a supine position. The secondary objective was to assess the correlation between T1rho and T2 values.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2015

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

Study Start

First participant enrolled

May 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 26, 2016

Last Update Submit

May 20, 2026

Conditions

Keywords

T1rho MRIhipcartilageHealthy participants

Outcome Measures

Primary Outcomes (1)

  • Quantification of the cartilage signal at T1rho MRI

    T1rho values of total hip cartilage and for each sub-region (mean, standard deviation, histogram)

    Up to one month after inclusion (Visit 1)

Secondary Outcomes (5)

  • Quantification of the cartilage signal at T1rho MRI

    15 (+/- 7) days after visit 1 (Visit 2)

  • Quantification of the cartilage signal at T2 MRI

    Up to one month after inclusion (Visit 1)

  • Quantification of the cartilage signal at T2 MRI

    15 (+/- 7) days after visit 1 (Visit 2)

  • Presence of cartilage lesions

    Up to one month after inclusion (Visit 1)

  • Presence of cartilage lesions

    15 (+/- 7) days after visit 1 (Visit 2)

Study Arms (1)

T1rho MRI

EXPERIMENTAL

Patients included had hip cartilage MRI with acquisition of T1rho MRI sequence.

Device: Hip cartilage MRI

Interventions

Hip cartilage MRI

T1rho MRI

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \<30
  • Accepting to participate in the study and signed the written informed consent
  • Covered by a health insurance system

You may not qualify if:

  • Pregnant woman or risk of pregnancy
  • MRI contraindication
  • Protected adults
  • Language barrier
  • Previous or current hip pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie

Lyon, 69437, France

Location

Related Publications (1)

  • Nemeth A, Di Marco L, Boutitie F, Sdika M, Grenier D, Rabilloud M, Beuf O, Pialat JB. Reproducibility of in vivo magnetic resonance imaging T1 rho and T2 relaxation time measurements of hip cartilage at 3.0T in healthy volunteers. J Magn Reson Imaging. 2018 Apr;47(4):1022-1033. doi: 10.1002/jmri.25799. Epub 2017 Jun 26.

Study Officials

  • Jean-Baptiste PIALAT, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 7, 2016

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations