NCT00669201

Brief Summary

Purpose:Evaluate the feasibility of T2 cartilage mapping on MRI of the wrist and correlate with T2 mapping of knee cartilage. Study protocol: Phase 1. 10 healthy volunteers, Phase 2. 10 volunteers with osteoarthritis of the wrist, Phase 3. 50 patients for studies for routine MR of the wrist. MRI protocol: 3 T unit((Signa EXITE HDx),T1, T2 and T2 mapping sequences on axial and coronal orientation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

December 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
Last Updated

April 30, 2008

Status Verified

April 1, 2008

First QC Date

April 28, 2008

Last Update Submit

April 29, 2008

Conditions

Keywords

cartilageosteoarthritisT2 mappingMRIWrist

Outcome Measures

Primary Outcomes (1)

  • wrist bone cartilage thickness can be measured and stratification can be observed on T2 mapping with correlation to T2 mapping of the knee cartilage

    Within MRI completion (20 minutes)

Study Arms (3)

1

healthy young volunteers Inclusion: age 18-40, Exclusion: wrist trauma/surgery

2

patients with know osteoarthritis wrist changes according to pre-existing x-rays No age limits exclusion: previous wrist surgery

3

Mixed group of 50 patients that perform routine MRI of the wrist for various indications

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers, volunteers with known osteoarthritis, routine MR population for wrist investigation

You may qualify if:

  • Phase 1. Age:18-40
  • Phase 2: No age limit, known OA on pre-existing X-rays
  • Phase 3: No age limit, routine MRI of the wrist

You may not qualify if:

  • Phase 1, 2: wrist trauma/surgery
  • All phases: any contraindication for MR: eg metals, claustrophobia, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba Medical Center , Diagnostic Imaging Dept

Tel Litwinsky, Tel Hashomer, 52621, Israel

RECRUITING

Sheba Medical Center, Diagnostic Imaging Dept

Tel Litwinsky, Tel Hashomer, 52621, Israel

ENROLLING BY INVITATION

Related Publications (3)

  • Glaser C. New techniques for cartilage imaging: T2 relaxation time and diffusion-weighted MR imaging. Radiol Clin North Am. 2005 Jul;43(4):641-53, vii. doi: 10.1016/j.rcl.2005.02.007.

    PMID: 15893528BACKGROUND
  • Recht MP, Goodwin DW, Winalski CS, White LM. MRI of articular cartilage: revisiting current status and future directions. AJR Am J Roentgenol. 2005 Oct;185(4):899-914. doi: 10.2214/AJR.05.0099.

    PMID: 16177408BACKGROUND
  • Mosher TJ, Dardzinski BJ, Smith MB. Human articular cartilage: influence of aging and early symptomatic degeneration on the spatial variation of T2--preliminary findings at 3 T. Radiology. 2000 Jan;214(1):259-66. doi: 10.1148/radiology.214.1.r00ja15259.

    PMID: 10644134BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Iris Eshed, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 30, 2008

Study Start

December 1, 2007

Last Updated

April 30, 2008

Record last verified: 2008-04

Locations