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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000632190
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
29/04/2019
Date last updated
29/04/2019
Date data sharing statement initially provided
29/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Development of a photon-count spectral (Computed Tomography) CT for human imaging; evaluation of the first human trials of the MARS Spectral CT
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Scientific title
Evaluation of MARS CT scan images in comparison to conventional CT images in patients and healthy volunteers
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Secondary ID [1]
296272
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None
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Universal Trial Number (UTN)
U1111-1221-8675
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
312443
0
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carotid atherosclerotic plaque
312444
0
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arthritis
312445
0
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fracture healing
312446
0
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Condition category
Condition code
Musculoskeletal
310992
310992
0
0
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Normal musculoskeletal and cartilage development and function
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Musculoskeletal
310993
310993
0
0
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Osteoarthritis
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Musculoskeletal
310994
310994
0
0
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Osteoporosis
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Cardiovascular
310995
310995
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Musculoskeletal
310997
310997
0
0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The MARS Human CT in similar in design and operation at a conventional CT. The MARS CT scanner consists of an x-ray source and detector rotating around the participant. The only noticeable difference compared to conventional CT is a longer scan duration. Typical MARS scans will be approximately twenty minutes in duration.
The MARS Human CT scanner will be used to scan the extremities of up to 200 study participants. One group of up to 100 normal participants will have CT scans of part of the upper and lower extremities on the MARS CT and commercial GE CT scanner . Normal participants may have up to four total scans. Initially participants will be invited to one scan on the MARS scanner and one scan on the GE (or equivalent) scanner. The participant may be invited to have up to two additional scans using revised or newly developed scan protocols as part of a continuous design improvement process. The other group of up to 100 invited participants will be referred by Consultants in rheumatology, orthopeadics, and vascular surgery to have MARS CT of affected limbs in conjunction with standard radiologic imaging. These participants will have a variable number of scans based on consult recommendations.
MARS CT scanning will be performed by the MARS Bioimaging Ltd staff at the University of Canterbury, Christchurch, New Zealand, under direction of MCNZ registered physicians and/or registered technologist. Scans on the GE scanner will be performed at Lincoln University, Lincoln, New Zealand. Images of participants will be compared by radiologists and consultants using the technique of Visual Grading Analysis (VGA) to determine if there are differences between scanners or modalities.
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Intervention code [1]
314229
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Diagnosis / Prognosis
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Comparator / control treatment
Conventional CT is defined as a commercially available approved CT scanner. One such unit is the GE HD750 scanner located at Lincoln University, Lincoln, New Zealand, Additional conventional CT scanners are located at Christchurch Hospital and Burwood Hospital, Christchurch, New Zealand
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome measurement will by statistical comparison of image quality as measured by a multiparametric Visual Grading Analysis for MARS and conventional CT
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Assessment method [1]
319790
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Timepoint [1]
319790
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End of study; imaging 60-200 normal participants
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Primary outcome [2]
319791
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For normal and participant, the outcome is whether MARS images are at least as good as conventional CT images (normal participants) or standard medical imaging (clinical-invited participants). Radiologists and clinical consultants will grade the MARS and conventional CT on multiple parameters (resolution, image noise, diagnostic utility, etc) using an ordinal numeric scoring system; e.g. -1, 0, +1 which will analyzed using the technique of VGA.
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Assessment method [2]
319791
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Timepoint [2]
319791
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End of study; imaging on up to 100 participants.
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Secondary outcome [1]
369539
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Nil
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Assessment method [1]
369539
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Timepoint [1]
369539
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Nil
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Eligibility
Key inclusion criteria
Normal participants: no know bone, joint, or vascular disease . Age forty and older.
Clinical participants: known bone, joint, or vascular disease, invited by consultant, age twenty-one and older
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Age under forty for normal participants, age under twenty-one f or clinical participants. Pregnancy or suspected pregnancy of female participants
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The technique of Visual Grading Analysis (VGA) will be used. MARS Spectral CT images will be compared to conventional CT images of the same anatomic region and scored by radiologists for diagnostic features and image quality. Scores (-1,0,+1) will be assigned to each comparison and scores will be subject to statistical analysis.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/05/2019
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Actual
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Date of last participant enrolment
Anticipated
30/09/2023
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Actual
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Date of last data collection
Anticipated
30/09/2023
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21418
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New Zealand
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State/province [1]
21418
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Canterbury
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Funding & Sponsors
Funding source category [1]
300865
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Government body
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Name [1]
300865
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Ministry of Business, Innovation, and Employment
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Address [1]
300865
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15 Stout Street, Wellington 6011
PO Box 1473, Wellington 6140
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Country [1]
300865
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New Zealand
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Primary sponsor type
University
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Name
University of Canterbury
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Address
Prof. Anthony Butler
West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
300421
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None
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Name [1]
300421
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Address [1]
300421
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Country [1]
300421
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301640
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Southern Health and Disabilities Ethics Committee
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Ethics committee address [1]
301640
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
New Zealand
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Ethics committee country [1]
301640
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New Zealand
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Date submitted for ethics approval [1]
301640
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25/10/2018
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Approval date [1]
301640
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10/04/2019
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Ethics approval number [1]
301640
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18/STH/221
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Summary
Brief summary
This research is to evaluate the MARS Spectral CT Scanner, Images of normal and abnormal extremities will be acquired with the MARS Spectral CT and conventional CT. MARS CT and conventional CT images will be compared using the technique of Visual Grading Analysis to determine if MARS Spectral CT is equivalent to or superior to conventional imaging.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
87630
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Prof Anthony Butler
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Address
87630
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West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
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Country
87630
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New Zealand
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Phone
87630
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+64 3 378 6359
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Fax
87630
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Email
87630
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[email protected]
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Contact person for public queries
Name
87631
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Prof Anthony Butler
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Address
87631
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West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
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Country
87631
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New Zealand
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Phone
87631
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+64 3 378 6359
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Fax
87631
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Email
87631
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[email protected]
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Contact person for scientific queries
Name
87632
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Prof Anthony Butler
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Address
87632
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West 414
University of Canterbury
Private Bag 4800
Christchurch 8140
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Country
87632
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New Zealand
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Phone
87632
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+64 3 378 6359
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Fax
87632
0
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Email
87632
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Limitations set by the participant consent form and restrictions on intellectual property owned by MARS Bioimaging, Ltd
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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.
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