Inflammation Clinical Trial
Official title:
PET Imaging of Hemophilic Arthropathy Correlates With Clinical, Radiographic and Sonographic Assessments
Verified date | April 2019 |
Source | Tri-Service General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Repeated hemarthroses in patients with hemophilia may lead to hemophilic arthropathy with marked inflammation and synovial hypertrophy. Power Doppler ultrasonography is a useful tool in hemophilic arthropathy for assessment of disease activity and for monitoring response to treatment. Imaging inflammation with glucose analogue fluorine-18-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is based on that infiltrated granulocytes and tissue macrophages use glucose as an energy source. Metabolism and 18F-FDG uptake increase when inflammation occurring. The purpose of this study is to investigate the associations between 18F-FDG PET/CT and Power Doppler assessment in patients with hemophilic arthropathy.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Age 20 years and above hemophilia A or B patients who reported history of hemarthroses of knee, ankle, elbow, shoulder or hip joints. Exclusion Criteria: - resence of joint infections, any surgery on the joints in preceding 6 months, history of rheumatoid arthritis or other inflammatory arthropathy, history of major trauma or presence of neoplasm around joints. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Hemophilia care and research center | Taipei |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUVmax | The analysis method is semi-quantitative and applied maximal standardized uptake (SUVmax) values. The SUVmax for each joint will be measured by placing regions of interest (ROIs) on the axial image of the joint. The SUVmax will be calculated as the maximum FDG uptake within the ROI divided by the injected dose over the patient's body weight (SUVmax = maximum pixel activity/[injected dose/body weight]). | 1 day | |
Secondary | Hyperemia | Power Doppler assessment of selected synovial sites is carried out with settings standardized to a pulse repetition frequency of 700 Hz. The power Doppler gain is adjusted to a level just below the disappearance of artifacts under the bony cortex (9, 13). The intensity of the blood flow in the synovium is scored into 0 to 3 (0=No flag; 1 = 1 flag; 2 = 2-3 flags; 3=>3 flags) adapted from Klukowska and Melchiorre et al | 1 day | |
Secondary | Pettersson score | The Pettersson score ranges from 0 to 13 and is based on the following radiographic features of joints: osteoporosis, osteophytes, narrowing of joint space, subchondral irregularity, subchondral cyst formation, erosion of joint margins, and bone remodelling. A totally normal joint has a score of zero. | 1 day | |
Secondary | ROM of joints | ROM of joint is measured in degrees with a goniometer. Shoulder:0-180; Elbow:0-150; Hip:0-120; Knee:0-135; Ankle:0-70 | 1 day | |
Secondary | Pain | The pain intensity will be evaluated subjectively on a visual analogue scale,0(no pain)-10cm(severe pain) | 1 day |
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