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.
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.
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.
- Conditions
- Hemophilia, Arthropathy, Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| PET | Other | Hemophilia 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.
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)
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
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
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
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.
- First posted2 Apr 2018
- Study start22 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsung-Ying Li, Tri-Service General Hospital (TSGH)
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Hemophilic Arthropathy Correlates With Clinical, Radiographic and Sonographic Assessments
- ClinicalTrials.gov ID
- NCT03485170
- Acronym / sponsor ID
- 2-106-05-028
- Conditions
- Hemophilia, Arthropathy, Inflammation
- Keywords
- Hemophilia, Hemophilic arthropathy, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET | Other | Diagnostic Test: 18F-FDG PET/CTHemophilia patients receive PET evaluation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 20 years and above hemophilia A or B patients who reported history of hemarthroses of knee, ankle, elbow, shoulder or hip joints.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CTglucose analogue fluorine-18-fluorodeoxyglucose positron emission tomography with computed tomography scan | Diagnostic test | PET |
Primary outcome
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]).
4 secondary outcomes
Hyperemia
Time frame: 1 day
Pettersson score
Time frame: 1 day
ROM of joints
Time frame: 1 day
Pain
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.