OsteoarthritisNCT00669201
Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study
An observational study of Osteoarthritis, run by Sheba Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 70 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers, volunteers with known osteoarthritis, routine MR population for wrist investigation
Who may be able to join
- 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
Who cannot join
- Phase 1, 2: wrist trauma/surgery
- All phases: any contraindication for MR: eg metals, claustrophobia, etc.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Sheba Medical Center , Diagnostic Imaging Dept
Tel HaShomer, Tel Hashomer, 52621
Iris Eshed, MD, 972-52-356-1121, Iris.Eshed@sheba.health.gov.il
Iris Eshed, MD
- Enrolling by invitation
Sheba Medical Center, Diagnostic Imaging Dept
Tel HaShomer, Tel Hashomer, 52621
About this study
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.
- Conditions
- Osteoarthritis
- Keywords
- cartilage, osteoarthritis, T2 mapping, MRI, Wrist
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
wrist bone cartilage thickness can be measured and stratification can be observed on T2 mapping with correlation to T2 mapping of the knee cartilage
Measured: Within MRI completion (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Iris Eshed, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669201
- Sponsor's protocol ID
- SHEBA-08-4912-IE-CTIL
- Status last verified
- Apr 2008
- First submitted
- 28 Apr 2008
- Last updated
- 30 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15893528Recht 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.
PubMed 16177408Mosher 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.
PubMed 10644134
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study
- ClinicalTrials.gov ID
- NCT00669201
- Acronym / sponsor ID
- SHEBA-08-4912-IE-CTIL
- Conditions
- Osteoarthritis
- Keywords
- cartilage, osteoarthritis, T2 mapping, MRI, Wrist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2007
- First posted
- 30 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers, volunteers with known osteoarthritis, routine MR population for wrist investigation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Phase 1, 2: wrist trauma/surgery
- All phases: any contraindication for MR: eg metals, claustrophobia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2008.
- Background: PubMed 15893528Glaser 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.
- Background: PubMed 16177408Recht 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.
- Background: PubMed 10644134Mosher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheba Medical Center , Diagnostic Imaging Dept
Tel HaShomer, Israel
Iris Eshed, MD principal investigator
Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00669201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2008.