Osteoarthritis, KneeNCT00820430
MRI Markers of Cartilage Damage in Knee With Osteoarthritis
An observational study of Osteoarthritis, Knee, run by American College of Radiology at 5 sites in United States.
Trial summary
The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 53 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2006to May 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This multi-center trial comprises only facilities within Pennsylvania. Study participants for the normal cohorts will be recruited through print flyers. It is anticipated that the study participants with mild to moderate OA will be identified by the radiologists interpreting the knee x-rays.
Who may be able to join
- Participants must be >18 years old;
- Participants must have a KL score between 0 and 3;
- Participants must have clearance to use protocol specified equipment: 3T MRI with parallel imaging capability and phased array knee coil (minimum 4 elements);
- Participant had no change of treatment occur within the last 6 months;
- Participants have no plans of changing to a different treatment within the next 3 months;
- Participant must provide a study-specific signed informed consent form.
Who cannot join
- Patients with contraindication to 3T MRI: Claustrophobia, Implanted metal or medical device that is not approved for MRI scanning at 3T, pregnancy, inability to tolerate relative immobility for 1 hour;
- Patients with prior knee surgery or trauma of the knee;
- Patients with KL score of 4.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19017
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis
The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced.
Read the detailed description
The development of a disease modifying osteoarthritis drugs (DMOADs) is currently limited by the inability to detect and monitor early cartilage damage that would be amenable to treatment. There is growing interest within the pharmaceutical and research community to use Magnetic Resonance Imaging (MRI) to identify biochemical and structural changes in the cartilage extra cellular matrix that occur early in the disease process. Although these techniques have been validated in small studies at single sites, multi-center evaluation of accuracy and precision, needed to apply these techniques to clinical trials of DMOADs, has not been performed. To address this need, the primary objective for this protocol is to identify and develop techniques to minimize systematic errors that decrease precision of MRI evaluation of knee cartilage, and to assess the reproducibility of the newly identified MRI techniques in measuring the cartilage morphometry and structure. Successful completion of this project may establish a multi-center imaging network in Pennsylvania for MRI evaluation of potential disease modifying osteoarthritis drugs (DMOADs) therapy.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Magnetic Resonance Imaging
- Keywords
- osteoarthritis, knee, magnetic resonance imaging, knee cartilage, reproducibility
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Also called MRI, knee MRI, knee magnetic resonance imaging
Subjects will undergo 4 sequential MRI evaluations of the target knee within a 4 week period to calculate precision error (ICC) in determination of cartilage morphometry (cartilage volume, mean thickness, and surface area), cartilage collagen (regional cartilage T2), and cartilage proteoglycan (regional cartilage T1rho).
| Study group | Role | What they receive |
|---|---|---|
| Control--Non-Osteoporotic Knee | Kellgren-Lawrence (KL) scale score of 0, Age: 18-35 years Receives: Other: Magnetic Resonance Imaging | |
| Minimal Osteoarthritis, Knee | Kellgren-Lawrence (KL) scale score of 1 or 2, Age: Older than 18; no upper limit Receives: Other: Magnetic Resonance Imaging | |
| Moderate Osteoarthritis, Knee | Kellgren-Lawrence (KL) scale score of 3, Age: Older than 18; no upper limit Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study goals are to develop and evaluate MRI techniques that minimize systematic errors in measuring knee cartilage, and to assess the reproducibility of MRI techniques comparing normal and osteoarthritic knees across institutions.
Measured: 4 sequental MRI evaluations of the target knee within a 4-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startNov 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Timothy J Mosher, MD, Principal investigator, Milton S. Hershey Medical CenterRavinder Reddy, PhD, Study chair, University of Pennsylvania, MMRRCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820430
- Sponsor's protocol ID
- ACRIN PA 4001
- Other IDs
- SAP #4100026182
- Status last verified
- Jul 2023
- First submitted
- 9 Jan 2009
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis
- ClinicalTrials.gov ID
- NCT00820430
- Acronym / sponsor ID
- ACRIN PA 4001
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, magnetic resonance imaging, knee cartilage, reproducibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Nov 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Jan 2009 (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.
The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced.
Detailed description
The development of a disease modifying osteoarthritis drugs (DMOADs) is currently limited by the inability to detect and monitor early cartilage damage that would be amenable to treatment. There is growing interest within the pharmaceutical and research community to use Magnetic Resonance Imaging (MRI) to identify biochemical and structural changes in the cartilage extra cellular matrix that occur early in the disease process. Although these techniques have been validated in small studies at single sites, multi-center evaluation of accuracy and precision, needed to apply these techniques to clinical trials of DMOADs, has not been performed. To address this need, the primary objective for this protocol is to identify and develop techniques to minimize systematic errors that decrease precision of MRI evaluation of knee cartilage, and to assess the reproducibility of the newly identified MRI techniques in measuring the cartilage morphometry and structure. Successful completion of this project may establish a multi-center imaging network in Pennsylvania for MRI evaluation of potential disease modifying osteoarthritis drugs (DMOADs) therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control--Non-Osteoporotic Knee | – | Other: Magnetic Resonance ImagingKellgren-Lawrence (KL) scale score of 0, Age: 18-35 years |
| Minimal Osteoarthritis, Knee | – | Other: Magnetic Resonance ImagingKellgren-Lawrence (KL) scale score of 1 or 2, Age: Older than 18; no upper limit |
| Moderate Osteoarthritis, Knee | – | Other: Magnetic Resonance ImagingKellgren-Lawrence (KL) scale score of 3, Age: Older than 18; no upper limit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This multi-center trial comprises only facilities within Pennsylvania. Study participants for the normal cohorts will be recruited through print flyers. It is anticipated that the study participants with mild to moderate OA will be identified by the radiologists interpreting the knee x-rays.
Key inclusion criteria (6 listed)
- Participants must be >18 years old;
- Participants must have a KL score between 0 and 3;
- Participants must have clearance to use protocol specified equipment: 3T MRI with parallel imaging capability and phased array knee coil (minimum 4 elements);
- Participant had no change of treatment occur within the last 6 months;
- Participants have no plans of changing to a different treatment within the next 3 months;
Key exclusion criteria (3 listed)
- Patients with contraindication to 3T MRI: Claustrophobia, Implanted metal or medical device that is not approved for MRI scanning at 3T, pregnancy, inability to tolerate relative immobility for 1 hour;
- Patients with prior knee surgery or trauma of the knee;
- Patients with KL score of 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRI, knee MRI, knee magnetic resonance imagingSubjects will undergo 4 sequential MRI evaluations of the target knee within a 4 week period to calculate precision error (ICC) in determination of cartilage morphometry (cartilage volume, mean thickness, and surface area), cartilage collagen (regional cartilage T2), and cartilage proteoglycan (regional cartilage T1rho). | Other | Control--Non-Osteoporotic Knee, Minimal Osteoarthritis, Knee, Moderate Osteoarthritis, Knee |
Primary outcome
The primary study goals are to develop and evaluate MRI techniques that minimize systematic errors in measuring knee cartilage, and to assess the reproducibility of MRI techniques comparing normal and osteoarthritic knees across institutions.
Time frame: 4 sequental MRI evaluations of the target knee within a 4-week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
Timothy J Mosher, MD principal investigator
Milton S. Hershey Medical Center
Ravinder Reddy, PhD study chair
University of Pennsylvania, MMRRCC
5 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, Knee, run by American College of Radiology at 5 sites in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary study goals are to develop and evaluate MRI techniques that minimize systematic errors in measuring knee cartilage, and to assess the reproducibility of MRI techniques comparing normal and osteoarthritic knees across institutions. (time frame: 4 sequental MRI evaluations of the target knee within a 4-week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2023.