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HemophiliaNCT03485170

PET Imaging of Hemophilic Arthropathy

A study testing 18F-FDG PET/CT in people with Hemophilia and Arthropathy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hemophilia, Arthropathy, Inflammation
What is being tested?
18F-FDG PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTaiwan
Study dates
22 Jan 2018to 31 Dec 2018
Phase
Interventional
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Hemophilia care and research center

    Taipei, 114

Other trials in Taiwan

About this study

Official title: PET Imaging of Hemophilic Arthropathy Correlates With Clinical, Radiographic and Sonographic Assessments

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.

Read the detailed description

The study will be performed at the Hemophilia Care and Research Center. We will recruit 20 participants. Inclusion criteria included age 20 years and above hemophilia A or B patients who reported history of hemarthroses of knee, ankle, elbow, shoulder or hip joints. Participants will be excluded for any of the following: presence 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.

We will collect clinically relevant information including age, body mass index (BMI), hemophilia type and severity, inhibitor titre, schedule of prophylaxis therapy with coagulation factor VIII or IX concentrates history of joint hemarthrosis, and bleeding events in the previous one year. The history of joint bleeding and the total number of joint bleeding events in the previous one year will be obtained from medical chart review recorded according to the patient's bleeding diaries.

18F-FDG PET /CT PET/CT will be performed using a Biograph PET/CT scanner (Discovery 710, GE Healthcare, WI, USA). All patients will fast except for water at least 6 hours prior to the examination. Sixty minutes after the intravenous injection of 10 mCi 18F-FDG, imaging will be performed using a spiral CT scan from the shoulder to the ankle with a 5 mm thickness per slice. Subsequently, PET data will be acquired in a supine position. The images will be reviewed by an experienced nuclear medicine physician unaware of the severity of hemophilic arthropathy in USG and plain x-ray. 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]).

Ultrasonography The USG assessment will be performed according to a standard technique using Terason t3000 machines (Teratech™ , Burlington, Massachusetts, USA) with a 5-12 MHz linear transducer. The probe scans the joint in the longitudinal view with the elbow in 90 degree flexion, or the knee or ankle in full extension. Synovium thickness and hyperemia were evaluated from the lateral, middle, and medial aspects of the anterior suprapatellar recess. 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. 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. Averages of synovium thickness and score of hyperemia in lateral, middle, and medial aspects of the joint will be calculated.

Radiological evaluation Anteroposterior and lateral plain radiographs of joints will be performed and scored according to Pettersson classification by the responsible orthopaedic specialist in our hemophilia center. 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. The Pettersson scoring system has been adopted by the World Federation of Hemophilia as the preferred radiographic classification system for hemophilic arthropathy.

Assessment of joint function ROM of joint is measured in degrees with a goniometer according to the American Academy of Orthopedic Surgeons guidelines. All ROM measurements will be performed by the same assessor. The pain intensity will be evaluated subjectively on a visual analogue scale.

For continuous data, the Student's t-test will be used if the data had a normal distribution. The Mann-Witney U test will be performed if a normal distribution was absent. For categorical data, the Chi-square test or Fisher's exact test will be used. The Spearman correlation coefficient will be calculated for each alteration. P value of less than 0.05 is considered statistically significant.

Being tested
18F-FDG PET/CT
Keywords
Hemophilia, Hemophilic arthropathy, PET
Medical subject headings
Hemophilia A, Joint Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FDG PET/CTDiagnostic test

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

Study groups in NCT03485170
Study groupRoleWhat they receive
PETOtherHemophilia patients receive PET evaluation
Receives: Diagnostic Test: 18F-FDG PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]).

    Measured: 1 day

Secondary outcomes (4)
  1. 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

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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

    Measured: 1 day

  4. Pain

    The pain intensity will be evaluated subjectively on a visual analogue scale,0(no pain)-10cm(severe pain)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study start22 Jan 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03485170
Sponsor's protocol ID
2-106-05-028
Status last verified
Apr 2019
First submitted
26 Mar 2018
Last updated
12 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 18F-FDG PET/CT in people with Hemophilia and Arthropathy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

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 1 inclusion and 1 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 12 Apr 2019. 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 Taiwan. 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.

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.

What does the primary outcome measure?

SUVmax (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Apr 2019.

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