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Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00669201
First Posted: April 30, 2008
Last Update Posted: April 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

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.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • wrist bone cartilage thickness can be measured and stratification can be observed on T2 mapping with correlation to T2 mapping of the knee cartilage [ Time Frame: Within MRI completion (20 minutes) ]

Estimated Enrollment: 70
Study Start Date: December 2007
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers, volunteers with known osteoarthritis, routine MR population for wrist investigation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Phase 1, 2: wrist trauma/surgery
  • All phases: any contraindication for MR: eg metals, claustrophobia, etc.
  Contacts and Locations
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): NCT00669201


Locations
Israel
Sheba Medical Center , Diagnostic Imaging Dept Recruiting
Tel Hashomer, Israel, 52621
Contact: Iris Eshed, MD    972-52-356-1121    Iris.Eshed@sheba.health.gov.il   
Principal Investigator: Iris Eshed, MD         
Sheba Medical Center, Diagnostic Imaging Dept Enrolling by invitation
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Eshed, MD Sheba Medical Center
  More Information

Publications:
Responsible Party: Iris Eshed, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00669201     History of Changes
Other Study ID Numbers: SHEBA-08-4912-IE-CTIL
First Submitted: April 28, 2008
First Posted: April 30, 2008
Last Update Posted: April 30, 2008
Last Verified: April 2008

Keywords provided by Sheba Medical Center:
cartilage
osteoarthritis
T2 mapping
MRI
Wrist

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases