Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014794
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-04-11
Brief Title:
Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis Patients
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
H215O Positron Emission Tomography PET in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 15O PET for the measurement of synovial blood flow in patients with RA In 10 RA patients with active knee synovitis clinical and radiological H2 15O PET and dynamic MRI evaluation will be performed The feasibility of H2 15O PET will be evaluated by its reproducibility We will also evaluate the correlation of dynamic MRI with synovial blood flow measurement by H2 15O PET
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 15O PET for the measurement of synovial blood flow in patients with RA In 10 RA patients with active knee synovitis clinical and radiological H2 15O PET and dynamic MRI evaluation will be performed The feasibility of H2 15O PET will be evaluated by its reproducibility We will also evaluate the correlation of dynamic MRI with synovial blood flow measurement by H2 15O PET
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-AR-0151 | None | None | None |