Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000662662
Ethics application status
Approved
Date submitted
11/06/2014
Date registered
24/06/2014
Date last updated
24/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Contrast Enhanced UltraSound to Magnetic Resonance Imaging for the detection of synovitis in patients with haemophilic arthropathy. A pilot study
Scientific title
Comparison of Contrast Enhanced UltraSound to Magnetic Resonance Imaging for the detection of synovitis in patients with haemophilic arthropathy. A pilot study
Secondary ID [1] 284659 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophiliac arthropathy 291984 0
Synovitis 292228 0
Condition category
Condition code
Musculoskeletal 292327 292327 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contrast enhanced ultrasound, a non ionising diagnostic imaging study using intravenously administered microbubble contrast ("Definity"). This study is performed on each participant on a single occasion for the affected joint, and takes approximately 30-45 minutes.
Intervention code [1] 289441 0
Diagnosis / Prognosis
Comparator / control treatment
Contrast enhanced MRI, a non ionising imaging study, which involves intravenous administration of gadolinium contrast. This study is performed on each participant on a single occasion for the affected joint, and takes approximately 30-45 minutes.
The MRI and US will take place on the same day.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292191 0
The relationship between the presence or absence of synovitis as determined by two experienced radiologists from contrast enhanced ultrasound (CE-US) and MRI will be determined.
Timepoint [1] 292191 0
Primary time point is the time of ultrasound and MRI.
Secondary outcome [1] 308399 0
Safety of Definity CE-US as determined by the number of adverse events using the Common Terminology Criteria for Adverse Events v 4 (CTCAE) form. Adverse effects are uncommon but include anaphylaxis (acute allergic reactions) and cardiovascular instability, such as low blood pressure.
Anaphylactic reactions range from urticaria (hives) and itching, to bronchospasm (muscle spasms of passages in the lungs) and facial and laryngeal edema (swelling).
Timepoint [1] 308399 0
Secondary time point is at the time of ultrasound and MRI and on review in clinic 2-4 weeks later.

Eligibility
Key inclusion criteria
Adult patients with haemophiliac arthropathy
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or breast feeding, right to left cardiovascular shunts, pulmonary hypertension, renal impairment, unstable cardiac disease, hypersensitivity to contrast agents

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
23/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289288 0
Hospital
Name [1] 289288 0
Alfred Hospital
Country [1] 289288 0
Australia
Primary sponsor type
Individual
Name
Dr Anne Powell
Address
The Alfred
PO Box 315
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 287959 0
Individual
Name [1] 287959 0
Dr Candice Law
Address [1] 287959 0
The Alfred
PO Box 315
Prahran VIC 3181
Country [1] 287959 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291054 0
Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 291054 0
The Alfred
PO Box 315
Prahran VIC 3181
Ethics committee country [1] 291054 0
Australia
Date submitted for ethics approval [1] 291054 0
01/02/2012
Approval date [1] 291054 0
06/05/2013
Ethics approval number [1] 291054 0
41/12

Summary
Brief summary
The aim of this project is to demonstrate that contrast enhanced ultrasound is an equally effective method for detecting synovitis in patients with haemophilia in whom the diagnosis of synovitis (joint capsule inflammation) from physical examination is unclear.

Currently, MRI is the screening tool for synovitis in this population; however it is time consuming, claustrophobic for some patients and has long waiting times.

Contrast-enhanced ultrasound is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents may be used during an ultrasound examination to improve the clarity and accuracy of a conventional ultrasound image.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48674 0
Dr Anne Powell
Address 48674 0
Alfred Hospital
Commercial Rd
Prahran, VIC 3181
Country 48674 0
Australia
Phone 48674 0
+61390762000
Fax 48674 0
Email 48674 0
[email protected]
Contact person for public queries
Name 48675 0
Dr Anne Powell
Address 48675 0
Alfred Hospital
Commercial Rd
Prahran, VIC 3181
Country 48675 0
Australia
Phone 48675 0
+61390762000
Fax 48675 0
Email 48675 0
[email protected]
Contact person for scientific queries
Name 48676 0
Dr Anne Powell
Address 48676 0
Alfred Hospital
Commercial Rd
Prahran, VIC 3181
Country 48676 0
Australia
Phone 48676 0
+61390762000
Fax 48676 0
Email 48676 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.