PET Imaging of Hemophilic Arthropathy

NCT03485170 | Completed

• 1 other identifier: 2-106-05-028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia; Arthropathy; Inflammation

Keywords

Hemophilia; Hemophilic arthropathy; PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hyperemia

  1 day

• Pettersson score

  1 day

• ROM of joints

  1 day

• Pain

  1 day

Study Arms (1)

PET

OTHER

Hemophilia patients receive PET evaluation

Diagnostic Test: 18F-FDG PET/CT

Interventions

18F-FDG PET/CT DIAGNOSTIC_TEST

glucose analogue fluorine-18-fluorodeoxyglucose positron emission tomography with computed tomography scan

PET

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years and above hemophilia A or B patients who reported history of hemarthroses of knee, ankle, elbow, shoulder or hip joints.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Hemophilia care and research center

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Hemophilia A; Joint Diseases; Inflammation

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: January 22, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)