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PET Imaging of Hemophilic Arthropathy

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ClinicalTrials.gov Identifier: NCT03485170
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tsung-Ying Li, Tri-Service General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemophilia Arthropathy Inflammation Diagnostic Test: 18F-FDG PET/CT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Imaging of Hemophilic Arthropathy Correlates With Clinical, Radiographic and Sonographic Assessments
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
PET
Hemophilia patients receive PET evaluation
Diagnostic Test: 18F-FDG PET/CT
glucose analogue fluorine-18-fluorodeoxyglucose positron emission tomography with computed tomography scan




Primary Outcome Measures :
  1. SUVmax [ Time Frame: 1 day ]
    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]).


Secondary Outcome Measures :
  1. Hyperemia [ Time Frame: 1 day ]
    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

  2. Pettersson score [ Time Frame: 1 day ]
    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.

  3. ROM of joints [ Time Frame: 1 day ]
    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

  4. Pain [ Time Frame: 1 day ]
    The pain intensity will be evaluated subjectively on a visual analogue scale,0(no pain)-10cm(severe pain)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485170


Locations
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Taiwan
Hemophilia care and research center
Taipei, Taiwan, 114
Sponsors and Collaborators
Tri-Service General Hospital

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Responsible Party: Tsung-Ying Li, Attending Physician, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03485170     History of Changes
Other Study ID Numbers: 2-106-05-028
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsung-Ying Li, Tri-Service General Hospital:
Hemophilia
Hemophilic arthropathy
PET

Additional relevant MeSH terms:
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Inflammation
Hemophilia A
Joint Diseases
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases