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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2008

Last Updated Date

April 29, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669201 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Biospecimen

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Study Group/Cohort (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00669201

Other Study ID Numbers ^ICMJE

SHEBA-08-4912-IE-CTIL

Has Data Monitoring Committee

Responsible Party

Iris Eshed, MD, Sheba Medical Center

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Iris Eshed, MD

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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