Rheumatoid ArthritisPhase 1NCT00014794
Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis Patients
A Phase 1 study testing 15-O labeled water in people with Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This study will test whether positron emission tomography (PET) imaging can be used to measure blood flow to joints in patients with rheumatoid arthritis (RA). It will also compare blood flow measurements using PET with measurements obtained with magnetic resonance imaging (MRI) to determine how useful MRI is in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 15-O labeled water
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2003
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years of age or greater.
- Must meet the American College of Rheumatology's diagnostic criteria for RA(21).
- Must have or have had synovitis in at least one knee characterized by tenderness, swelling, or effusion within 30 days prior to screening.
- Women must test negative on a pregnancy test unless they are post-menopausal or surgically sterile.
Who cannot join
- Patients with concurrent known bacterial, septic, or crystal-induced arthritis, or with other rheumatic diseases that may confound the analysis including but not limited to Lyme disease, psoriatic arthritis, spondylarthropathy, systemic lupus erythematosus, or reactive arthritis.
- Patients who would be beyond the guidelines for radiation exposure from research studies within the past year.
- Patients who exceed the size or weight limitations of the PET or MRI scanner.
- Patients who suffer from claustrophobia or who have any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc), metal fragments in the eye, or shrapnel injuries.
- Any musculoskeletal, neurological, or vascular condition that may alter the normal function and structure of knee joint of interest or will interfere the patient's ability to undergo study-related intervention and imaging.
- Any clinically significant medical condition that, in the opinion of the investigator, would pose added risk for study participants.
- History of allergic or non-allergic serious reaction to gadolinium, or H2 15O PET.
- Pregnant women or nursing mothers.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
About this study
Official title: H215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients
This study will test whether positron emission tomography (PET) imaging can be used to measure blood flow to joints in patients with rheumatoid arthritis (RA). It will also compare blood flow measurements using PET with measurements obtained with magnetic resonance imaging (MRI) to determine how useful MRI is in measuring blood flow to joints.
Much of the joint damage in RA is caused by the synovium-the lining of the joint. In RA, the synovium increases in size and destroys bone and cartilage. The synovium maintains its growth by forming many new small blood vessels to nourish it. New drug treatments are being developed to stop the growth of these new blood vessels. The effect of these treatments on the synovium is usually measured by performing a biopsy-removing a small piece of synovium for examination under a microscope. The biopsy requires inserting a needle into the joint to withdraw the synovial tissue. This study will see if changes in blood flow can be assessed accurately using noninvasive imaging procedures, such as PET scanning, instead of a biopsy.
Read more
Patients 18 years of age and older with rheumatoid arthritis who have at least one tender and swollen knee due to synovitis may be eligible for this study. Candidates will be screened with a medical history and physical examination.
Participants will have a mold made of the knee to be studied and will have routine blood tests. Women who are able to become pregnant will have a pregnancy test. All participants will then undergo PET and MRI scanning as described below:
PET - A needle is used to insert a catheter (small plastic tube) into an arm vein for injection of the radioactive substance H215O. The patient lies in a doughnut-shaped machine (the PET scanner) and a quick scan is done to measure body thickness. Then, a separate scan is taken following each of six or fewer injections of H215O. Each scan lasts about 13 minutes.
MRI - The patient lies on a stretcher that is moved into a cylinder containing a magnetic field (the MRI scanner). A special coil is placed over the knee to improve the quality of the images. Earplugs are worn to muffle the loud thumping sound produced by electrical switching of the magnetic fields during the imaging. A contrast agent called gadolinium is injected through a catheter into a vein to improve the quality of the images. An intercom system permits the patient to communicate with the technician at all times during the procedure.
Read the detailed description
Because of the proliferative nature of rheumatoid synovial tissue, many new pharmaceuticals are targeting angiogenesis inhibition as a means of halting synovial growth. Although clinical markers of rheumatoid arthritis (RA) activity may function as surrogate endpoints in trials of these new agents, a non-invasive technique of assessing synovial blood flow would be the ideal outcome measure.
PET imaging has been used to quantify blood flow to a variety of tissues, with significant experience at this institution in the area of tumor blood flow analysis.
The objective of this study is to evaluate the feasibility of H2 (15)O PET for the measurement of synovial blood flow in patients with RA. In 10 RA patients with active knee synovitis, clinical and radiological (H2 (15)O PET and dynamic MRI) evaluation will be performed. The feasibility of H2 (15)O PET will be evaluated by its reproducibility. We will also evaluate the correlation of dynamic MRI with synovial blood flow measurement by H2 (15)O PET.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 15-O labeled water
- Keywords
- Arthritis, Vascularity, Angiogenesis, Imaging, MRI, Rheumatoid Arthritis, PET Scan, Synovitis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15-O labeled waterDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2001 (estimated)
- Study startApr 2001
- Study completionMar 2003
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 Rheumatoid ArthritisStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014794
- Sponsor's protocol ID
- 010151
- Other IDs
- 01-AR-0151
- Status last verified
- Mar 2003
- First submitted
- 11 Apr 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Choudhury L, Elliott P, Rimoldi O, Ryan M, Lammertsma AA, Boyd H, McKenna WJ, Camici PG. Transmural myocardial blood flow distribution in hypertrophic cardiomyopathy and effect of treatment. Basic Res Cardiol. 1999 Feb;94(1):49-59. doi: 10.1007/s003950050126.
PubMed 10097830Eliceiri BP, Cheresh DA. The role of alphav integrins during angiogenesis: insights into potential mechanisms of action and clinical development. J Clin Invest. 1999 May;103(9):1227-30. doi: 10.1172/JCI6869. No abstract available.
PubMed 10225964Walsh DA. Angiogenesis and arthritis. Rheumatology (Oxford). 1999 Feb;38(2):103-12. doi: 10.1093/rheumatology/38.2.103.
PubMed 10342621
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT00014794
- Acronym / sponsor ID
- 010151
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, Vascularity, Angiogenesis, Imaging, MRI, Rheumatoid Arthritis, PET Scan, Synovitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Apr 2001
- Study completion
- Mar 2003
- First posted
- 12 Apr 2001 (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.
This study will test whether positron emission tomography (PET) imaging can be used to measure blood flow to joints in patients with rheumatoid arthritis (RA). It will also compare blood flow measurements using PET with measurements obtained with magnetic resonance imaging (MRI) to determine how useful MRI is in measuring blood flow to joints.
Much of the joint damage in RA is caused by the synovium-the lining of the joint. In RA, the synovium increases in size and destroys bone and cartilage. The synovium maintains its growth by forming many new small blood vessels to nourish it. New drug treatments are being developed to stop the growth of these new blood vessels. The effect of these treatments on the synovium is usually measured by performing a biopsy-removing a small piece of synovium for examination under a microscope. The biopsy requires inserting a needle into the joint to withdraw the synovial tissue. This study will see if changes in blood flow can be assessed accurately using noninvasive imaging procedures, such as PET scanning, instead of a biopsy.
Patients 18 years of age and older with rheumatoid arthritis who have at least one tender and swollen knee due to synovitis may be eligible for this study. Candidates will be screened with a medical history and physical examination.
Participants will have a mold made of the knee to be studied and will have routine blood tests. Women who are able to become pregnant will have a pregnancy test. All participants will then undergo PET and MRI scanning as described below:
PET - A needle is used to insert a catheter (small plastic tube) into an arm vein for injection of the radioactive substance H215O. The patient lies in a doughnut-shaped machine (the PET scanner) and a quick scan is done to measure body thickness. Then, a separate scan is taken following each of six or fewer injections of H215O. Each scan lasts about 13 minutes.
MRI - The patient lies on a stretcher that is moved into a cylinder containing a magnetic field (the MRI scanner). A special coil is placed over the knee to improve the quality of the images. Earplugs are worn to muffle the loud thumping sound produced by electrical switching of the magnetic fields during the imaging. A contrast agent called gadolinium is injected through a catheter into a vein to improve the quality of the images. An intercom system permits the patient to communicate with the technician at all times during the procedure.
Detailed description
Because of the proliferative nature of rheumatoid synovial tissue, many new pharmaceuticals are targeting angiogenesis inhibition as a means of halting synovial growth. Although clinical markers of rheumatoid arthritis (RA) activity may function as surrogate endpoints in trials of these new agents, a non-invasive technique of assessing synovial blood flow would be the ideal outcome measure.
PET imaging has been used to quantify blood flow to a variety of tissues, with significant experience at this institution in the area of tumor blood flow analysis.
The objective of this study is to evaluate the feasibility of H2 (15)O PET for the measurement of synovial blood flow in patients with RA. In 10 RA patients with active knee synovitis, clinical and radiological (H2 (15)O PET and dynamic MRI) evaluation will be performed. The feasibility of H2 (15)O PET will be evaluated by its reproducibility. We will also evaluate the correlation of dynamic MRI with synovial blood flow measurement by H2 (15)O PET.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or greater.
- Must meet the American College of Rheumatology's diagnostic criteria for RA(21).
- Must have or have had synovitis in at least one knee characterized by tenderness, swelling, or effusion within 30 days prior to screening.
- Women must test negative on a pregnancy test unless they are post-menopausal or surgically sterile.
Key exclusion criteria (8 listed)
- Patients with concurrent known bacterial, septic, or crystal-induced arthritis, or with other rheumatic diseases that may confound the analysis including but not limited to Lyme disease, psoriatic arthritis, spondylarthropathy, systemic lupus erythematosus, or reactive arthritis.
- Patients who would be beyond the guidelines for radiation exposure from research studies within the past year.
- Patients who exceed the size or weight limitations of the PET or MRI scanner.
- Patients who suffer from claustrophobia or who have any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc), metal fragments in the eye, or shrapnel injuries.
- Any musculoskeletal, neurological, or vascular condition that may alter the normal function and structure of knee joint of interest or will interfere the patient's ability to undergo study-related intervention and imaging.
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 |
|---|---|---|
| 15-O labeled water | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 10097830Choudhury L, Elliott P, Rimoldi O, Ryan M, Lammertsma AA, Boyd H, McKenna WJ, Camici PG. Transmural myocardial blood flow distribution in hypertrophic cardiomyopathy and effect of treatment. Basic Res Cardiol. 1999 Feb;94(1):49-59. doi: 10.1007/s003950050126.
- Background: PubMed 10225964Eliceiri BP, Cheresh DA. The role of alphav integrins during angiogenesis: insights into potential mechanisms of action and clinical development. J Clin Invest. 1999 May;103(9):1227-30. doi: 10.1172/JCI6869. No abstract available.
- Background: PubMed 10342621Walsh DA. Angiogenesis and arthritis. Rheumatology (Oxford). 1999 Feb;38(2):103-12. doi: 10.1093/rheumatology/38.2.103.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 15-O labeled water in people with Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site 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 4 inclusion and 8 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 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014794, 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 4 Mar 2008.