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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00669201
First received: April 28, 2008
Last updated: April 29, 2008
Last verified: April 2008
  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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 28, 2008
Last Updated: April 29, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014