Feasibility and Reproducibility of T1 Rho MRI in the Evaluation of Hip Cartilage

Healthy Volunteers Clinical Trial

— CARHAT02  

Official title:

Feasibility and Reproducibility of T1 Rho MRI in the Evaluation of Hip Cartilage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792010
• Other study ID #: 69HCL14_0235
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: January 11, 2017
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• BMI <30

• Accepting to participate in the study and signed the written informed consent

• Covered by a health insurance system

Exclusion Criteria:

• Pregnant woman or risk of pregnancy

• MRI contraindication

• Protected adults

• Language barrier

• Previous or current hip pain

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Hip cartilage MRI
Hip cartilage MRI

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Quantification of the cartilage signal at T1rho MRI	T1rho values of total hip cartilage and for each sub-region (mean, standard deviation, histogram)	15 (+/- 7) days after visit 1 (Visit 2)	No
Secondary	Quantification of the cartilage signal at T2 MRI	T2 values of total hip cartilage and for each sub-region (mean, standard deviation, histogram)	Up to one month after inclusion (Visit 1)	No
Secondary	Quantification of the cartilage signal at T2 MRI	T2 values of total hip cartilage and for each sub-region (mean, standard deviation, histogram)	15 (+/- 7) days after visit 1 (Visit 2)	No
Secondary	Presence of cartilage lesions	Morphological sequence to determine focal lesions	Up to one month after inclusion (Visit 1)	No
Secondary	Presence of cartilage lesions	Morphological sequence to determine focal lesions	15 (+/- 7) days after visit 1 (Visit 2)	No